Kamada (KMDA)

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Kedrion and Kamada Announce FDA Approval of KEDRAB® Label Update, Confirming Safety and Effectiveness in Children

https://finance.yahoo.com/news/kedrion-kamada-announce-fda-approval-110000060.html

Wed, June 2, 2021, 2:00 PM

[b]Label Expansion Differentiates KEDRAB® as the First and Only Human Rabies Immune Globulin (HRIG) Available in the U.S. to be Clinically Studied in Children

KEDRAB Product Label Now Includes Patients of All Ages

New FDA Approval Based on Safety and Effectiveness of KEDRAB in the Pediatric Population Demonstrated in a U.S. Post Marketing Clinical Trial


World Health Organization Estimates up to 40 Percent of People Exposed to a Suspected Rabid Animal are Children Under 15 Years of Age

FORT LEE, N.J. and REHOVOT, Israel, June 02, 2021 (GLOBE NEWSWIRE) -- Kedrion Biopharma and Kamada Ltd. (NASDAQ & TASE: KMDA), two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics, announced today the U.S. Food and Drug Administration (FDA) has approved a label update for KEDRAB® (Rabies Immune Globulin [Human]), establishingthe product’s safety and effectiveness in children.

KEDRAB, a human rabies immune globulin (HRIG), is now indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection in persons of all ages when given promptly following contact with a rabid or possibly rabid animal. The new updates to the KEDRAB label are based on data from the KEDRAB U.S. post marketing Pediatric Study, the first and only clinical trial to establish pediatric safety and effectiveness of any HRIG in the U.S.

Additional evidence to support the use of KEDRAB in children comes from real world evidence. According to Centers for Disease Control and Prevention (CDC) data,no children in the U.S. treated with post-exposure prophylaxis have been reported to have had rabies between 2018 and April 2021.

Rabies is a life-threatening disease, but it is fully preventable if treated on time. It impacts approximately 40,000 people in the U.S. each year. According to the World Health Organization (WHO), up to 40 percent of people exposed to a suspected rabid animal are children under 15 years of age.

"Improving the lives of people with rare and serious diseases is our most important mission at Kedrion Biopharma,” said Kedrion Biopharma Chief Executive Officer, Val Romberg. “As the U.S. market’s first and only human rabies immune globulin to be studied in children, KEDRAB is an excellent example of that dedication. Today’s news will provide added peace of mind for physicians who choose KEDRAB in treating children who have possibly been exposed to rabies. We are especially proud of our partnership with Kamada, which has resulted in this significant step forward in global health.”

“Kamada is excited to have a HRIG that can treat people of all ages in the U.S. with the FDA-approved label expansion for KEDRAB,” said Amir London, Chief Executive Officer of Kamada. “We believe that this label update may support an increase of KEDRAB’s U.S. market share. We anticipate that sales of KEDRAB will continue to grow meaningfully in the U.S., capturing a significant portion of the estimated annual $150 million U.S. HRIG market.”

Kamada has been selling the HRIG product since 2003 in numerous territories outside of the U.S. under the brand name KAMRAB®.

Kamada sold approximately 5 million ml of KamRAB to date, demonstrating significant clinical experience with the product. Under the clinical development and marketing agreement between Kedrion Biopharma and Kamada, Kamada holds the license for KEDRAB and Kedrion Biopharma has exclusive rights to commercialize the product in the U.S.

About KEDRAB®
KEDRAB® [Rabies Immune Globulin (Human)] is a human rabies immune globulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection in persons of all ageswhen given promptly after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine.

KEDRAB was approved by the FDA in August, 2017. KEDRAB is supplied in single-dose vials containing 2 mL or 10 mL of ready-to-use solution with a nominal potency of 150 IU/mL.

KEDRAB should be administered concurrently with a full course of rabies vaccine.

Important Safety Information:

Severe hypersensitivity reactions, including anaphylaxis, may occur with KEDRAB. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions.

KEDRAB is made from human plasma donors and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeld-Jacob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Please see KEDRAB full prescribing Information for complete prescribing details. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About the KEDRAB® U.S. Pediatric Clinical Study
KEDRAB’s safety and effectiveness have been established in children. KEDRAB was evaluated in a two-center, open-label clinical trial in 30 pediatric patients exposed or possibly exposed to rabies virus for whom post-exposure prophylaxis (PEP) was indicated. The primary objective of the study was to confirm the safety of KEDRAB in the pediatric population.

The patients were treated with KEDRAB at a dose of 20 IU/kg on Day 0 and active rabies vaccine on Days 0, 3, 7, and 14 as per the Advisory Committee on Immunization Practices (ACIP) recommendations for rabies PEP. The patients ranged in age from 0.5 to 14.9 years; 46.7 percent were females, 6.7 percent were Asian, 23.3 percent were Black or African American and 70 percent were White.

Rabies virus neutralizing antibody (RVNA) titers and tolerability were assessed on day 14 following administration. Participant safety was monitored for 84 days. No serious adverse reactions, rabies infections, or deaths were recorded through day 84.

Of the 30 patients, 28 (93.3 percent) achieved a Day-14 RVNA titer ≥0.5 IU/mL, the World Health Organization recommended level. This secondary objective included the evaluation of antibody levels and effectiveness of KEDRAB in the prevention of rabies disease when administered with a rabies vaccine, according to the rabies PEP guidelines recommended by ACIP.

View the published U.S. Pediatric Clinical Study here.

About Rabies
Rabies is a preventable viral disease of mammals most often transmitted through the bite of a rabid animal. It is a serious and nearly always fatal infection. In the U.S., rabies in wild animals, especially raccoons, skunks, foxes and bats, accounts for most cases of rabies passed on to humans, pets, and other domestic animals. An acute, progressive viral encephalomyelitis, rabies carries the highest case fatality rate of any conventional etiological agent. Rabies is one of the oldest described infectious diseases, known for over 5,000 years.