CHMP recommends BAY 81-8973 for prophylactic treatment of Haemophilia A- Bayer HealthCare + CSL Behring
The European Committee for Medicinal Products for Human Use (CHMP) has recommended BAY 81-8973, Bayer�s new recombinant factor VIII compound, for approval in the EU for the treatment and prophylaxis of bleeding in patients with hemophilia A for all age groups. BAY 81-8973 is an unmodified full-length recombinant factor VIII compound that, in clinicals trials, has demonstrated control of bleeds and protection from bleeds in hemophilia A patients when used prophylactically two or three times per week.
The final decision of the European Commission on the marketing authorization is expected in the coming weeks. Hemophilia affects approximately 400,000 people around the world and is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints or internal organs. The positive CHMP recommendation 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 children, adolescents and adults using both, prophylaxis dosing regimens and on-demand treatment.
Under a supply agreement CSL Behring has rights to market the molecule under the submitted trade mark Iblias.
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