Bayer announces FDA acceptance of BAY 81-8973 BLA for treatment of hemophilia A

Bayer HealthCare today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for BAY 81-8973, a recombinant Factor VIII compound. Bayer is seeking FDA approval of the investigational compound, proposed trade name Kovaltry™, for the treatment of hemophilia A in children and adults.

"Bayer is committed to continually bringing new therapies to hemophilia A patients who need them," said David Weinreich, M.D., Head, Global Development, Specialty Medicine, Bayer HealthCare Pharmaceuticals. "Today's milestone represents the next step in that commitment."

The BLA is based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which evaluated BAY 81-8973 in adults and children using two- and three-times-per-week prophylaxis dosing regimens. The LEOPOLD Clinical Development Program consists of three multinational clinical trials designed to evaluate the pharmacokinetics, efficacy, and safety of BAY 81-8973 in subjects with severe hemophilia A (<1% FVIII:C).

BAY 81-8973 is an investigational agent and is not approved by the United States FDA, the European Medicines Agency (EMA) or other health authorities.

Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is a largely inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A is the most common type of hemophilia and is characterized by prolonged or spontaneous bleeding, especially into the joints, muscles or internal organs. It is estimated that 20,000 people are living with hemophilia in the U.S. today.

Bayer HealthCare is committed to delivering science for a better life by advancing a portfolio of treatments. Hematology at Bayer HealthCare includes numerous compounds in various stages of development for hemophilia, sickle cell anemia, and other blood and bleeding disorders. Together, these compounds reflect the company's commitment to research and development, prioritizing specific targets for intervention with the potential to improve the way that rare blood and bleeding disorders are treated.

SOURCE Bayer HealthCare


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
How Aloe vera's medicinal properties make it essential in medicine, cosmetics, and food products