Anavex Life Sciences Corp (AVXL)

[Investor2014]

Nice! Georgejjl is catching up getting a little bit more right by the day 😀

Anavex Received Agreement from the Committee for Medicinal Products for Human Use (CHMP) for the Submission of a Marketing Authorisation Application of Oral Blarcamesine for Alzheimer’s Disease

NEW YORK – December 19, 2023
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, announced today that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agreed that oral blarcamesine for Alzheimer’s disease is eligible for submission of an application for a Union Marketing Authorisation in the EU under the European Medicines Agency’s centralised procedure.


The granting of the eligibility from the CHMP under the centralised procedure allows for submission of a single Marketing Application to the European Medicines Agency that, if approved, would allow blarcamesine to be marketed in all EU member states. Anavex is aiming to submit the Marketing Authorisation Application as early as possible in 2024.



“We appreciate the CHMP/EMA’s decision to deem blarcamesine eligible for a centralised regulatory review,” said Anavex’s Christopher U Missling, PhD, President and Chief Executive Officer. “We understand that there is a need for scalable and accessible treatments options which can be pragmatically administered like oral blarcamesine not requiring any complex additional procedures for the treatment of people with Alzheimer’s disease.”



There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030[1], which could be addressed by blarcamesine.



Since blarcamesine requires only a physician assessed diagnosis of Alzheimer’s disease and not any invasive amyloid positron emission tomography (PET) scans or lumbar punctures (spinal tap), the potential addressable market for blarcamesine consist of a broader Alzheimer’s disease population compared to the class of drugs called monoclonal antibodies, which require a minimum threshold of amyloid measured by PET or spinal tap. According to a recent NIH-funded analysis, applying the clinical trial eligibility criteria for monoclonal antibodies resulted in only a small fraction of participants with Alzheimer’s disease being eligible to receive treatment.[2]



The ANAVEX®2-73-AD-004 Alzheimer’s disease placebo-controlled Phase 2b/3 trial showed that in addition to significant improvement in dementia symptoms, blarcamesine demonstrated reduction of pathological aggregation of amyloid in early Alzheimer’s disease as well reduction of brain volume loss, a well-known marker of neurodegeneration.



Data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized, placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal.