Bayer HealthCare today announced that it has filed a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of hemophilia A in adults and children. BAY 81-8973 is a full-length recombinant factor VIII which has demonstrated clinical evidence of efficacy when used in standard dosage for prophylaxis two times or three times per week. The submission follows Bayer’s recent application to the European Medicines Agency (EMA) for approval of the same indication in the European Union. Bayer plans to submit BAY 81-8973 for approval in other countries in the coming weeks and months.

“Data from our comprehensive clinical program LEOPOLD suggest that BAY 81-8973 could become an important new treatment option for people with hemophilia A”, said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “We are committed to improve the lives of people with hemophilia A, and will continue to invest in research and development for innovative treatments.”

For more details, go to: http://www.news.bayer.com/baynews/baynews.nsf/id/Bayer-Submits-Application-US-FDA-Approval-Recombinant-Factor-VIII-Product-BAY-81-8973-Treatment?OpenDocument&sessionID=1418953786