Bayer HealthCare today submitted an application for marketing authorization to the European Medicines Agency (EMA) for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of hemophilia A in children and adults. BAY 81-8973 is a full-length recombinant factor VIII which has demonstrated clinical evidence of efficacy when used for prophylaxis twice or three times per week, with standard dosages. Bayer plans to file BAY 81-8973 for approval in other countries in the coming months. 

“Clinical data from the LEOPOLD trials show that BAY 81-8973 provides bleeding control in people with severe hemophilia A when infused either twice per week or three times per week – with standard dosages,“ said Johannes Oldenburg, MD, PhD, member of the Clinical Study Steering Committee and Head of the University of Bonn’s Institute of Experimental Hematology and Transfusion Medicine. “Flexible dosing gives patients and their doctors greater choice in matching the right treatment regimen to each person’s therapeutic requirements.”

“Bayer has long had a strong commitment to the hemophilia community, and the submission of BAY 81-8973 is an important step forward in our efforts to improve treatment options for people with hemophilia”, said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

For more details, go to: http://www.news.bayer.com/baynews/baynews.nsf/id/Bayer-Submits-Marketing-Authorization-Application-Europe-Recombinant-Factor-VIII-Product-BAY-81-8973?OpenDocument&sessionID=1417996354