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Biogen Submits Biologics License Application to FDA for First Long-Lasting Factor IX Therapy for Hemophilia B


Today Biogen
Idec (NASDAQ: BIIB) announced the company recently submitted a
Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) for the marketing approval of recombinant factor IX
Fc fusion protein (rFIXFc) for the treatment of hemophilia 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 3 clinical study in hemophilia B to

“The submission to FDA of rFIXFc is an important milestone towards the

See full press release

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