Biogen Idec files rFIXFc at FDA for treatment of Haemophilia B
Biogen Idec has submitted a Biologics License Application (BLA) to the FDA for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of Haemophilia B.
rFIXFc is the first product candidate in a new class of long-lasting clotting factor therapies that are being developed with the goals of reducing the burden of treatment for this condition and enhancing protection from bleeding. The regulatory submission was based on results from B-LONG, the largest registrational phase III clinical study in Haemophilia B to date.
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