Biogen Idec, Inc. (Massachusetts) (BIIB) Submits Application to FDA for First Long-Lasting Factor VIII Therapy for Hemophilia A
3/12/2013 9:26:57 AM
WESTON, Mass.--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) announced today that the company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of 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 will be the first major advance in hemophilia A treatment in more than two decades. The regulatory submission was based on results from A-LONG, the largest registrational phase 3 clinical study in hemophilia A to date.