BAY 81 8973 filed at EMA for treatment of Haemophilia A in children and adults- BayerHealthCare

Bayer HealthCare 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 Haemophilia 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 Haemophilia 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.�