Biogen Idec announced that the FDA has accepted its Biologics License Application (BLA) for marketing approval of recombinant factor IX FC fusion protein (rFIXFc) for the treatment of hemophilia B and granted the company a standard review timeline. Recombinant FIXFC is the first product candidate in a new class of long-lasting clotting factor therapies being developed using Biogen Idec’s monomeric Fc fusion technology, which makes use of a naturally occurring pathway that delays the destruction of factor and cycles it back into the bloodstream, resulting in a longer circulating half-life.
The submission was based on results from B-LONG, the largest registrational phase 3 clinical study in hemophilia B to date. The study demonstrated that rFIXFC provides long-lasting protection from bleeding with fewer injections than are required with the current standard of care.
Biogen’s BLA submission for rFVIIIFc for use in patients with hemophilia A is on track for filing during the first half of 2013.
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