Biogen Idec (BIIB) reported submitting a Biologics License Application or BLA to the U.S. Food and Drug Administration or FDA for the marketing approval of recombinant factor VIII Fc fusion protein or rFVIIIFc to treat hemophilia A. Recombinant FVIIIFc is the first hemophilia A product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of reducing the burden of treatment for this condition.
If approved, rFVIIIFc would be the first major advance in hemophilia A treatment in more than two decades, according to the company. The regulatory submission was based on results from A-LONG, the largest registrational phase 3 trial in hemophilia A to date.
Biogen Idec added, "In our phase 3 study, patients treated with rFVIIIFc were able to inject rFVIIIFc once-weekly to twice-weekly, which creates the potential for those currently on prophylactic treatment to reduce injections by 50 to 100 per year. Moreover, patients currently treating bleeding episodes could potentially dose prophylactically once per week and maintain significant protection from bleeding with about the same total number of injections each year they use to treat bleeding episodes today."
On March 4, 2013 Biogen Idec announced the FDA accepted for review the company's BLA for its factor IX candidate, rFIXFc, for use in patients with hemophilia B.
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