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news.The US Food and Drug Administration (FDA) has accepted Bayer HealthCare's biologics license application (BLA) for BAY 81-8973 (Kovaltry), a recombinant Factor VIII compound, for the treatment of hemophilia A in children and adults.
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The BLA is based on results from the LEOPOLD clinical trials, which evaluated BAY 81-8973 in adults and children using two- and three-times-per-week prophylaxis dosing regimens.
The trials, which are part of the LEOPOLD Clinical Development Program, evaluated the pharmacokinetics, efficacy, and safety of BAY 81-8973 in subjects with severe hemophilia A.
Bayer HealthCare Pharmaceuticals head Global Development, Specialty Medicine David Weinreich said: "Bayer is committed to continually bringing new therapies to hemophilia A patients who need them."
Currently, the investigational agent BAY 81-8973 is not approved by the FDA, the European Medicines Agency (EMA) or other health authorities.
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is characterized by prolonged or spontaneous bleeding, especially into the joints, muscles or internal organs.