BAY 81 8973 filed with FDA for Haemophilia A-Bayer HealthCare
Bayer HealthCare has submitted a Biologics License Application (BLA) to the FDA seeking approval for BAY 81 8973, (recombinant Factor VIII or rFVIII), for the treatment of Hemophilia A in children and adults. The submission 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. An application for marketing authorization for BAY 81 8973 was submitted to the EMA in December 2014 for approval of the same indication in the European Union.
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