The U.S. regulator clears Biogens' (BIIB) Eloctate (antihemophilic factor (recombinant) Fc fusion protein) for the control and prevention of bleeding episodes, perioperative management and routine prophylaxis in adults and children with hemophilia A. It is the first recombinant therapy with prolonged circulation in the body and it offers hemophilia patients the potential to extend the interval between prophylactic infusions. The recommended starting prophylactic regimen is 50 IU/kg every four days.
In a 165-patient Phase 3 clinical trial of males 12 years and older with severe hemophilia A, prophylactic treatment with Eloctate achieved a statistically significant reduction of bleeding episodes compared to on-demand treatment. 98% of bleeding episodes were controlled with one or two Eloctate infusions.
Biogen expects to launch the product commercially in the U.S. in July.