FDA Accepts Biogen Idec, Inc. (Massachusetts) (BIIB)'s Biologics License Application for First Long-Lasting Factor IX Therapy for Hemophilia B
3/4/2013 10:07:40 AM
WESTON, Mass.--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the 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 with the goal of reducing the burden of treatment for hemophilia B.
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