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Bayer files BLA for BAY 81-8973 to treat Hemophilia A in adults and children

Bayer HealthCare has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking approval for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, to treat hemophilia A in children and adults.

The BLA was 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.

BAY 81-8973, an investigational agent, has showed clinical evidence of efficacy when used in standard dosage for prophylaxis two times or three times per week.

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.

Bayer HealthCare Pharmaceuticals vice president and head of US Medical Affairs Dario Mirski said: "The LEOPOLD study program and the submission of BAY 81-8973 are a demonstration of Bayer’s continued, longstanding commitment to the hemophilia A community."

BAY 81-8973 is not approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other health authorities.

The submission follows Bayer’s recent application to the European Medicines Agency (EMA) for approval of the same indication in the EU.

The company plans to submit BAY 81-8973 for approval in other countries in the coming weeks and months.