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Synapticure Launches Groundbreaking Ataxia Care Program, Expanding Access to Specialized Neurology Nationwide
July 16, 2026 7:47 AM
PR Newswire (US)
Virtual-first, multidisciplinary care model delivers care for adults living with ataxias, connecting them to expert neurologist options nationwide.
CHICAGO, July 16, 2026 /PRNewswire/ -- Synapticure, a leading virtual care company dedicated to improving access and outcomes for patients and caregivers living with neurodegenerative diseases, today announced the launch of a virtual ataxia care program. This program can help to provide timely access to specialized care for adults living with ataxias — a group of neurological conditions characterized by progressive loss of coordination, balance, and motor function. Synapticure partnered with Biogen Inc. (Nasdaq: BIIB) to support disease education and awareness efforts of this resource, helping to address a critical gap in access to care for the ataxia community. Biogen is not involved in developing, administering, or responsible for the Synapticure healthcare services, clinical considerations, or patient care. Adults with ataxias can receive specialized neurological care from Synapticure's care team or be co-managed alongside their existing care team.
With this expansion, Synapticure adds to its comprehensive virtual platform for neurodegenerative care in the United States, now extending its reach to serve individuals living with ataxias across the country.
"For people living with ataxias and their families, accessing expert neurological care is often a years-long struggle," said Sandra Abrevaya, CEO and Co-Founder of Synapticure. "Synapticure was built to change that dynamic — to expand access to specialized neurological expertise directly to patients where they live, and to make personalized, proactive care the standard rather than the exception. We are proud to now open our doors to the ataxia community."
Ataxias affect tens of thousands of people in the United States1. With a growing landscape of disease-modifying research, the need for informed, ataxia-knowledgeable care has never been greater.
"Highly specialized ataxia care and expertise can be difficult to find locally, posing a significant challenge for individuals and families," said Kristen Fortino, Head of the U.S. Rare Disease Franchise at Biogen. "Our commitment to people living with rare neurological diseases, including the broader ataxia community, extends beyond treatment. We are dedicated to providing meaningful support every step of the care journey including supporting greater awareness of available care resources."
Synapticure's ataxia care program will be led by Dr. Elizabeth Ferluga, MD, Director of Movement Disorders at Synapticure, who brings deep clinical expertise in movement disorders and a longstanding commitment to rare neurological conditions. Dr. Ferluga and the Synapticure clinical team can provide patients with access to specialized evaluations, genetic counseling, and comprehensive longitudinal care — all delivered virtually by Synapticure's independent healthcare providers.
"Patients with ataxias are a community that has been underserved by the traditional healthcare system for far too long," said Dr. Elizabeth Ferluga, MD, Director of Movement Disorders at Synapticure. "The Synapticure model is transformative for this population — we can meet patients where they are, perform a thorough evaluation, help them understand their diagnosis and what it means for them and their families, provide information about potential clinical trials, and be a consistent, knowledgeable partner in their care over time. I am incredibly excited to bring this level of support to the ataxia community."
Synapticure's ataxia care program can provide patients with:
As with all conditions Synapticure providers can treat, Synapticure can serve as a patient's primary neurologist, where permitted or work in collaboration with other physicians on a patient's existing care team. The Synapticure model is designed to complement, not replace, any existing specialist relationships a patient may have. Synapticure operates independently and is solely responsible for its clinical services and patient care.
Patients living with ataxias anywhere in the United States can visit synapticure.com/with/ataxia or call (708) 630-1534 to schedule an intake appointment or learn more about Synapticure's services.
About Synapticure
Founded by Sandra Abrevaya, Brian Wallach, Peter Wallach, and Jason Langheier, Synapticure is a patient- and caregiver-founded virtual care provider offering access to expert neurologists, cutting-edge treatments and trials, wraparound care coordination, and behavioral health support in all 50 states. Partnering with providers and health plans, including CMS' GUIDE dementia care model, Synapticure is dedicated to transforming the lives of millions of individuals and their families living with neurodegenerative diseases like Alzheimer's, Parkinson's, ALS, and now ataxias. For more information, visit www.synapticure.com.
Synapticure's medical group, CareND, is in-network with Medicare and various commercial insurance plans, with new payer agreements added regularly. Where CareND is not yet in-network, claims will be submitted as an out-of-network provider. The Synapticure billing team is committed to cost transparency, providing patients with a cost estimate prior to any visit. Patients without insurance or those who prefer to pay out of pocket will be informed of visit costs in advance. Coverage and out-of-pocket costs vary based on a patient's health plan and individual circumstances.
Media Contact
References:
1. National Ataxia Foundation. What is Ataxia? Available at: https://www.ataxia.org/what-is-ataxia/. Last accessed: May 2026.
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SOURCE Synapticure
LEQEMBI® Real-World LEADER Study Presented at AAIC® 2026 Finds Over 75% of Early Alzheimer's Patients Enrolled in the Study Remained Stable and Nearly 7% Improved Over an Average of 17 Months of Treatment
July 14, 2026 11:15 AM
PR Newswire (US)
Real-World Findings Support Long-Term Benefits of Continuous Treatment with LEQEMBI and Provide Important Insights into Treatment Experience Outside of a Clinical Trial Setting
TOKYO and CAMBRIDGE, Mass., July 14, 2026 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that results from the real-world Lecanemab in Early Alzheimer's Disease (LEADER) Study show that nearly 83% of early Alzheimer's disease (AD) patients enrolled in the study remained stable (75.9%) or improved (6.6%) while receiving LEQEMBI® therapy over an average of 17 months. The results were consistent across sex, race, ethnicity and APOE genotype. The data was presented during the "Developing Topics Session #3-33-DEV-A: Lecanemab Three Years Post-Approval: A Comprehensive Multicenter, Real-World, Retrospective Study (LEADER) in Diverse US Clinical Settings" at the Alzheimer's Association International Conference® (AAIC®) 2026 in London and online.
AD is a chronic, progressive disease that requires ongoing treatment. LEQEMBI targets the underlying pathology of the disease and works in two ways throughout treatment - by removing insoluble (plaque) and soluble amyloid beta (protofibrils), helping to slow cognitive decline and loss of daily functioning. Data show continued treatment with LEQEMBI may be able to help keep patients in early AD for longer. Early AD includes mild cognitive impairment (MCI) due to AD and mild AD dementia.
LEADER Study Design
The three-year LEADER Study is a multicenter, retrospective real-world study designed to examine LEQEMBI utilization, treatment persistence, transition to maintenance therapy, safety, cognitive and functional assessments, and healthcare professional (HCP) implementation learnings in diverse U.S. clinical settings for patients with early Alzheimer's disease (AD). The study integrated deidentified chart and electronic medical record (EMR) data from 13 U.S. sites, HCP surveys and HCP interviews. This interim analysis included 432 patients with early AD who received at least seven LEQEMBI infusions as of May 2026.
Patient Characteristics at Baseline
Disease Stage at Baseline
Treatment
LEADER Study Key Findings
Real-World Evidence Shows Long-Term Benefit with Continuous LEQEMBI Treatment Across Sex, Race, Ethnicity and APOE Genotype
Overall Study Population Findings
Maintenance Dosing Population Findings
Real-World Safety Consistent with U.S. FDA-Approved Label
Overall safety observations in this real-world study were consistent with the U.S. FDA-approved label.
APOE e4 status safety observations were consistent with the overall cohort and the U.S. FDA-approved label.
Antithrombotic therapy, including anticoagulants or antiplatelet medications, was used by 106 patients, representing 24.5% of the study population.
* ARIA refers to amyloid-related imaging abnormalities that can be observed with anti-amyloid beta antibody treatment and includes ARIA-E, which involves edema/effusion, and ARIA-H, which involves hemosiderin deposition, including cerebral microhemorrhage, cerebral macrohemorrhage and superficial siderosis, as observed on brain magnetic resonance imaging (MRI).
Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
MEDIA CONTACTS
| |
Eisai Co., Ltd. Public Relations Department TEL: +81 (0)3-3817-5120
Eisai Europe, Ltd. EMEA Communications Department +44 (0)7760 619251
Eisai Inc. (U.S.) Julie Edelman +1-862-213-5915 | Biogen Inc. Madeleine Shin +1-781-464-3260 |
INVESTOR CONTACTS | |
Eisai Co., Ltd. Investor Relations Department TEL: +81 (0) 3-3817-5122 |
Biogen Inc. Tim Power +1-781-464-2442 |
Notes to Editors
About lecanemab (generic name, brand name: LEQEMBI®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß).
Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 8 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved LEQEMBI IQLIK, the subcutaneous autoinjector formulation of lecanemab, for use as maintenance treatment in August 2025 and as initiation treatment on July 13, 2026. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. Since December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China.
Since July 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S., funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.
About Protofibrils
Protofibrils are thought to be the most toxic Aß species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.1 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aß plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.2
Limitations of Real-World Studies
Retrospective real-world studies can be valuable in providing additional information to complement clinical trial data; however, there are potential limitations to consider, including: potential for biases, data completeness and consistency, lack of a control group, interpretation of data due to lack of placebo-controlled arms, and confounding variables, and data inconsistency. Data inconsistency may be mitigated by providing site access to standardized electronic case-report forms.
About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.
Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for lecanemab-irmb (LEQEMBI IQLIK); the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.
These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov.
These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q, Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.
References
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SOURCE Eisai Inc.
FDA Approves LEQEMBI IQLIK® (lecanemab-irmb) Subcutaneous Injection as an Initiation Dose for Early Alzheimer's Disease
July 13, 2026 5:36 PM
PR Newswire (US)
LEQEMBI IQLIK is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home dosing for initiation and maintenance (approved in the U.S.)
U.S. launch of LEQEMBI IQLIK as an initiation dose planned for late August 2026
TOKYO and CAMBRIDGE, Mass., July 13, 2026 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (brand name: LEQEMBI IQLIK®) as an initiation dose for the treatment of early Alzheimer's disease.
Experience the full interactive Multichannel News Release here: https://www.multivu.com/Eisai/9406151-en-fda-approves-leqembi-for-early-alzheimers-disease
LEQEMBI IQLIK is administered via an autoinjector, introducing a convenient alternative to intravenous (IV) dosing from the start of treatment. For initiation, the approved regimen is 500 mg given once weekly as two 250 mg injections, each delivered in approximately 15 seconds. LEQEMBI IQLIK may also be used for maintenance dosing at 360 mg once weekly after 18 months of IV or subcutaneous treatment. Throughout the entire treatment course – from initiation through maintenance – patients may receive LEQEMBI either as IV infusion or as subcutaneous (SC) injection with LEQEMBI IQLIK. Patients may also switch from IV to SC administration, or vice versa, providing greater convenience and flexibility in LEQEMBI administration.
LEQEMBI is indicated in the United States for adults with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease, collectively referred to as early Alzheimer's disease. MCI due to AD is the earliest symptomatic stage of Alzheimer's disease and can appear with subtle symptoms such as forgetfulness, confusion, or feeling at a loss for words.
Clinical Data Supporting FDA Approval of Subcutaneous Initiation Dosing
The FDA approval of LEQEMBI IQLIK as an initiation dose is supported by a comprehensive clinical data package evaluating SC administration of lecanemab across multiple studies and a range of dosing regimens. Sub-studies within the Phase 3 Clarity AD long-term extension (LTE), following the 18-month core study in individuals with early Alzheimer's disease, showed:
"The approval of LEQEMBI IQLIK for initiation dosing marks a new era of Alzheimer's treatments," said Howard Fillit, MD, Co-Founder and Chief Science Officer Emeritus of the Alzheimer's Drug Discovery Foundation (ADDF). "For the first time, patients and their care partners have meaningful choice in how anti-amyloid treatment is delivered. As treatment approaches continue to expand, innovations in drug delivery will play a critical role in improving access to therapies, supporting the investigation of potential combination treatments, and advancing a precision medicine approach to Alzheimer's care."
Expanding Treatment Flexibility Across the Alzheimer's Disease Care Pathway
The approval of LEQEMBI IQLIK as a subcutaneous initiation dose provides patients and care partners with the only at-home administration option throughout the Alzheimer's disease treatment journey which could support access and delivery of care across healthcare settings. Subcutaneous administration may:
Insights from an autoinjector acceptability study indicated that 94% of patients with early Alzheimer's disease and their care partners found the LEQEMBI IQLIK device easy to use, with high levels of satisfaction and confidence in using it in an at-home setting.*
Support for Patients
The LEQEMBI CompanionTM program offers help with understanding insurance coverage and potential out-of-pocket costs, and identifying financial support programs, including the LEQEMBI Copay Assistance Program for eligible patients.
To further support access to LEQEMBI for certain patients who need help paying for their medicines, Eisai's Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost, for eligible uninsured patients, who meet financial need and other program criteria.
LEQEMBI IQLIK for initiation dosing is expected to be available in late August 2026 in the U.S. Patients will receive LEQEMBI IQLIK from a specialty pharmacy.
Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
*Based on in-person interviews of 50 patients with early AD and 50 care partners currently assisting people with early AD. Participants were given the opportunity to interact with a training autoinjector device (containing no needles or medication) and an injection pad, then asked to answer computer-based surveys about their experience, including "How difficult or easy was it to use the self-injection device?"
INDICATION
LEQEMBI® is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
IMPORTANT SAFETY INFORMATION
WARNING: AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA) • Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause ARIA, characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal. Serious intracerebral hemorrhages (ICH) >1 cm, some of which have been fatal, have been observed with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI. o Apolipoprotein E e4 (ApoE e4) Homozygotes: Patients who are ApoE e4 homozygotes (~15% of patients with AD) treated with this class of medications have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE e4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with LEQEMBI; however, it cannot be determined if they are ApoE e4 homozygotes and at higher risk for ARIA. • Consider the benefit of LEQEMBI for the treatment of AD and the potential risk of serious ARIA events when deciding to initiate treatment with LEQEMBI. |
CONTRAINDICATION
Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis.
WARNINGS AND PRECAUTIONS
AMYLOID-RELATED IMAGING ABNORMALITIES
Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.
Incidence of ARIA
Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%. ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo.
Incidence of ICH
ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed.
Risk Factors of ARIA and ICH
ApoE e4 Carrier Status
Of the patients taking LEQEMBI, 16% were ApoE e4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE e4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE e4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE e4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE e4 carriers and noncarriers.
Radiographic Findings of CAA
Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE e4 allele is also associated with CAA.
The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH.
Concomitant Antithrombotic or Thrombolytic Medication
In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo.
Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent.
Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with LEQEMBI.
Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for ICH and, in particular, patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA.
Radiographic Severity With LEQEMBI
Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE e4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE e4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%).
Monitoring and Dose Management Guidelines
Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.
HYPERSENSITIVITY REACTIONS
Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.
INFUSION-RELATED REACTIONS (IRRs)
IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.
IRRs can occur during or after the completion of infusion. In the event of an IRR during the infusion, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.
ADVERSE REACTIONS
LEQEMBI (lecanemab-irmb) is available:
Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.
Click here to access the LEQEMBI digital library with assets available for download.
MEDIA CONTACTS | |
Eisai Co., Ltd. Public Relations Department TEL: +81 (0)3-3817-5120 Eisai Europe, Ltd. EMEA Communications Department +44 (0) 7760 619251 Eisai Inc. (U.S.) Libby Holman +1-201-753-1945 | Biogen Inc. Madeleine Shin +1-781-464-3260 |
| |
Eisai Co., Ltd. Investor Relations Department TEL: +81 (0) 3-3817-5122 | Biogen Inc. Tim Power + 1-781-464-2442 |
Notes to Editors
Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.
References
View original content:https://www.prnewswire.com/news-releases/fda-approves-leqembi-iqlik-lecanemab-irmb-subcutaneous-injection-as-an-initiation-dose-for-early-alzheimers-disease-302824254.html
SOURCE Eisai Inc.
LEQEMBI® Subcutaneous Autoinjector Clinical Data Supports Similar Efficacy and Safety to IV Formulation in Early Alzheimer's Disease Presented at the Alzheimer's Association International Conference® (AAIC®) 2026
July 12, 2026 11:15 AM
PR Newswire (US)
New clinical and real-world data support a subcutaneous treatment pathway from initiation through maintenance treatment, offering dosing convenience for patients and care partners
TOKYO and CAMBRIDGE, Mass., July 12, 2026 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that new data presented at the Alzheimer's Association International Conference® (AAIC®) 2026 in London support that the LEQEMBI® (lecanemab) subcutaneous autoinjector (SC-AI) formulation offers efficacy and safety comparable to intravenous (IV) administration for people with early Alzheimer's disease (AD). The data was featured during the "Lecanemab Subcutaneous Formulation in Early Alzheimer's Disease: Emerging Clinical Evidence and Practical Use Considerations" Developing Topics Session #1-32-FRS-C.
AD is a chronic, progressive disease that requires ongoing treatment. LEQEMBI is an early AD treatment that targets the underlying pathology of the disease, helping to slow cognitive decline and loss of daily functioning. The lecanemab subcutaneous auto-injector (SC-AI) was developed to provide a more convenient alternative to intravenous (IV) dosing from the initiation of treatment.
Key Findings
This session presented data from the lecanemab SC-AI development program in early Alzheimer's disease, including pharmacokinetic (PK), pharmacodynamic (PD), efficacy, safety and real-world patient and care partner experience findings. Results showed that once-weekly 500 mg SC-AI achieved drug exposure similar to the approved intravenous (IV) initiation regimen (10 mg/kg every two weeks), supporting the expectation of similar clinical efficacy and safety, independent of the route of administration.
If approved by the United States Food and Drug Administration (FDA), subcutaneous dosing for initiation may offer a convenient at-home alternative to IV infusion which could support access and delivery of care across healthcare settings.
Data Showed
Safety Profile Aligned of SC LEQEMBI
Clinical Trial Perspectives and Real-World Evidence: Sustained Clinical Benefit with SC-AI
Results presented in this session further reinforce the importance of early and continuous treatment, highlighting how LEQEMBI SC initiation and maintenance administration provides greater optionality for long-term disease management.
Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.
MEDIA CONTACTS | |
Eisai Co., Ltd. Public Relations Department TEL: +81 (0)3-3817-5120
Eisai Europe, Ltd. EMEA Communications Department +44 (0) 797 487 9419
Eisai Inc. (U.S.) Libby Holman +1201-753-1945
| Biogen Inc. Madeleine Shin +1-781-464-3260 |
INVESTOR CONTACTS
| |
Eisai Co., Ltd. Investor Relations Department TEL: +81 (0) 3-3817-5122 | Biogen Inc. Tim Power + 1-781-464-2442 |
Notes to Editors
About lecanemab (generic name, brand name: LEQEMBI®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß).
Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 8 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China.
Since July 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai, and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.
About Protofibrils
Protofibrils are thought to be the most toxic Aß species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.1 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aß plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.2
About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient's lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.
Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for lecanemab-irmb (LEQEMBI IQLIK); the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.
These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov.
These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q, Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.
References
View original content to download multimedia:https://www.prnewswire.com/news-releases/leqembi-subcutaneous-autoinjector-clinical-data-supports-similar-efficacy-and-safety-to-iv-formulation-in-early-alzheimers-disease-presented-at-the-alzheimers-association-international-conference-aaic-2026-302823332.html
SOURCE Eisai Inc.
Update on FDA Priority Review of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection as a Starting Dose for Early Alzheimer's Disease
May 8, 2026 2:30 AM
PR Newswire (US)
TOKYO and CAMBRIDGE, Mass., May 8, 2026 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIK™) as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act (PDUFA) action date is August 24, 2026.
As part of the ongoing review process, the agency requested additional information and has determined that it constituted a major amendment to the sBLA, extending the PDUFA date to allow sufficient time for a full review of the additional materials. The FDA has not raised any concerns to date regarding the approvability of LEQEMBI IQLIK as a starting dose.
Eisai and Biogen believe that the comprehensive clinical data package evaluating subcutaneous administration of LEQEMBI across multiple studies and dosing regimens strongly supports the potential use of LEQEMBI IQLIK for initiation therapy, following FDA approval of the subcutaneous maintenance dosing regimen on August 26, 2025.
LEQEMBI has been approved by more than 50 regulatory authorities worldwide, reflecting broad regulatory confidence in LEQEMBI as a treatment option for early Alzheimer's disease.
Eisai and Biogen look forward to ongoing discussions with the FDA as the review progresses and are committed to bringing this important advancement to patients and care partners as quickly as possible to provide greater flexibility and choice in how anti-amyloid treatment is delivered.
INDICATION
LEQEMBI® is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
IMPORTANT SAFETY INFORMATION
WARNING: AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA)
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CONTRAINDICATION
Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis.
WARNINGS AND PRECAUTIONS
Amyloid-Related Imaging Abnormalities
Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.
Incidence of ARIA
Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%. ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo.
Incidence of ICH
ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed.
Risk Factors of ARIA and ICH
ApoE e4 Carrier Status
Of the patients taking LEQEMBI, 16% were ApoE e4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE e4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE e4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE e4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE e4 carriers and noncarriers.
Radiographic Findings of CAA
Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE e4 allele is also associated with CAA.
The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH.
Concomitant Antithrombotic or Thrombolytic Medication
In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo.
Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent.
Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with LEQEMBI.
Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for ICH and, in particular, patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA.
Radiographic Severity With LEQEMBI
Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE e4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE e4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%).
Monitoring and Dose Management Guidelines
Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.
Hypersensitivity Reactions
Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.
Infusion-Related Reactions (IRRs)
IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.
IRRs can occur during or after the completion of infusion. In the event of an IRR during the infusion, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.
ADVERSE REACTIONS
LEQEMBI (lecanemab-irmb) is available:
Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.
MEDIA CONTACTS | |
Eisai Co., Ltd. Public Relations Department TEL: +81 (0)3-3817-5120 Eisai Inc. (U.S.) Julie Edelman +1-862-213-5915 Julie_Edelman@eisai.com | Biogen Inc. Madeleine Shin +1-781-464-3260 |
INVESTOR CONTACTS | |
Eisai Co., Ltd. Investor Relations Department TEL: +81 (0) 3-3817-5122 | Biogen Inc. Tim Power + 1-781-464-2442 |
Notes to Editors
Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for lecanemab-irmb (LEQEMBI IQLIK); the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.
These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov.
These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q, Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.
View original content to download multimedia:https://www.prnewswire.com/news-releases/update-on-fda-priority-review-of-leqembi-iqlik-lecanemab-irmb-subcutaneous-injection-as-a-starting-dose-for-early-alzheimers-disease-302766585.html
SOURCE Eisai Co., Ltd.
Bright Horizons Family Solutions and Remitly Global Set to Join S&P SmallCap 600
May 7, 2026 6:01 PM
PR Newswire (US)
NEW YORK, May 7, 2026 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P SmallCap 600 effective prior to the opening of trading on Thursday, May 14:
Following is a summary of the changes that will take place prior to the open of trading on the effective date:
Effective Date | Index Name | Action | Company Name | Ticker | GICS Sector | |
May 14, 2026 | S&P SmallCap 600 | Addition | Bright Horizons Family Solutions | BFAM | Consumer Discretionary | |
May 14, 2026 | S&P SmallCap 600 | Deletion | Tri Pointe Homes | TPH | Consumer Discretionary | |
May 14, 2026 | S&P SmallCap 600 | Addition | Remitly Global | RELY | Financials | |
May 14, 2026 | S&P SmallCap 600 | Deletion | Apellis Pharmaceuticals | APLS | Health Care | |
ABOUT S&P DOW JONES INDICES
S&P Dow Jones Indices is the largest global resource for essential index-based concepts, data and research, and home to iconic financial market indicators, such as the S&P 500® and the Dow Jones Industrial Average®. More assets are invested in products based on our indices than products based on indices from any other provider in the world. Since Charles Dow invented the first index in 1884, S&P DJI has been innovating and developing indices across the spectrum of asset classes helping to define the way investors measure and trade the markets.
S&P Dow Jones Indices is a division of S&P Global (NYSE: SPGI), which provides essential intelligence for individuals, companies, and governments to make decisions with confidence. For more information, visit www.spglobal.com/spdji/en/.
FOR MORE INFORMATION:
S&P Dow Jones Indices
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Media Inquiries
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View original content:https://www.prnewswire.com/news-releases/bright-horizons-family-solutions-and-remitly-global-set-to-join-sp-smallcap-600-302766326.html
SOURCE S&P Dow Jones Indices
Original: Bright Horizons Family Solutions and Remitly Global Set to Join S&P SmallCap 600
Results from Real-World, Long-Term Treatment Persistence with LEQEMBI® (lecanemab-irmb) in the United States Presented at AD/PD™ 2026
March 20, 2026 12:05 PM
PR Newswire (US)
Real-World LEQEMBI Data Shows Patients Choose to Stay on Long-Term Treatment
TOKYO and CAMBRIDGE, Mass., March 20, 2026 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that new real-world findings from an analysis of long-term treatment persistence and baseline characteristics among people receiving intravenous (IV) lecanemab (generic name, brand name LEQEMBI®), an anti-amyloid-ß (Aß) protofibril antibody, showed that most patients continue with ongoing lecanemab therapy after the initial 18 months of treatment. The analysis was presented at the 20th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2026) in Copenhagen, Denmark, and online.
In real-world clinical practice, patients with chronic diseases who stay on their treatments longer tend to experience better clinical outcomes and higher satisfaction.1,2 Ninety-four percent of patients who completed 18 months of lecanemab treatment in the Phase III Clarity AD study chose to continue maintenance treatment by enrolling in the subsequent open-label, long-term extension (OLE) study. In the OLE of the Clarity AD study, patients continue to benefit from four years of lecanemab treatment compared with the natural course of Alzheimer's disease (Alzheimer's Disease Neuroimaging Initiative: ADNI*).
Long-Term Persistence and Patient Characteristics for Lecanemab in Real-World Use in the United States (Presentation: March 20, 17:05 CET)
This analysis is the first time real-world lecanemab data on treatment persistence beyond 18 months has been reported.
This study was a retrospective observational analysis using the PurpleLab® CLEAR Claims database, a comprehensive dataset based on medical insurance claims across the United States and was conducted to evaluate the long-term treatment persistence of lecanemab in real-world clinical practice.
¦ Patient background and dosing
The analysis population consisted of 10,763 individuals who met the requirement for continuous healthcare encounters, out of the 13,388 individuals recorded in the database who received at least one IV treatment with lecanemab between January 6, 2023 and November 30, 2025. At baseline, the mean age was 73.8 years and 56.5% were female. The most common comorbidities were dyslipidemia (42.2%) and hypertension (36.9%). The mean follow-up duration was 350.9 days. The average number of administrations was 1.7 per month, and the mean dosing interval was 16.4 days (median 14 days), which was generally consistent with the recommended every two weeks dosing.
¦ Long-Term persistence results
The time-dependent proportion of patients who remained on lecanemab treatment was evaluated using the Kaplan–Meier method in a subgroup of 371 patients who initiated treatment in 2023 and had 20 months of continuous follow-up, thereby enabling assessment of long-term treatment persistence beyond 18 months. As a result, 78.4% of individuals continued lecanemab treatment at 18 months, 71.7% at 20 months, and 67.3% at 24 months. Of the 78.4% of patients who remained on lecanemab at 18 months, the majority of them continued treatment during the maintenance period beyond 18 months, confirming a high rate of treatment persistence with lecanemab in real-world clinical practice. The patient characteristics and dosing patterns observed in this claims-based analysis were generally similar to those reported in the Clarity AD study. Furthermore, the relatively high treatment adherence observed among individuals suggests that potential delays due to MRI monitoring requirements, adverse events, and other factors did not substantially affect lecanemab dosing.
Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
* ADNI is a clinical research project launched in 2005 to develop methods to predict the onset and progression of AD and to confirm the effectiveness of treatments. The project involves a multi-year longitudinal observation targeting healthy elderly individuals as well as patients with mild cognitive impairment (MCI) and early stages of AD.
[Notes to Editors]
Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab (marketed as LEQEMBI); the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for LEQEMBI (lecanemab) subcutaneous autoinjector (SC-AI); the potential to expand options and reduce healthcare resources by treating Alzheimer's disease at home; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "outlook," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would" or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.
These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov.
These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
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References
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SOURCE Eisai Inc.
$BIIBFirst, @P_McCulloughMD who is one of the most published people in the world on Covid vaccine myocarditis spoke.
— Anna Matson (@AnnaRMatson) May 22, 2025
He saw warning signs as early as August of 2021 that the vaccines can cause myocarditis… pic.twitter.com/Gexd9yXOhU
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