Bayer Healthcare announced that the FDA has accepted for review the Biologics License Application (BLA) for Kovaltry (BAY 81-8973), a recombinant Factor VIII compound for the treatment of hemophilia A in children and adults.

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The BLA submission 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 clinical trials designed to evaluate the pharmacokinetics, efficacy, and safety of BAY 81-8973 in subjects with severe hemophilia A (<1% FVIII:C).

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