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.
"We are encouraged by the FDA's acceptance of our application, as we believe rFIXFc has the potential to transform the care of hemophilia B by allowing for less frequent injections and helping patients to maintain low annualized bleeding rates," said Glenn Pierce, M.D., Ph.D., senior vice president of Global Medical Affairs and chief medical officer of Biogen Idec's hemophilia therapeutic area. "We are working with the FDA to bring the first major treatment advance for the hemophilia B community in 15 years."
The regulatory submission was based on results from B-LONG, the largest registrational phase 3 clinical study in hemophilia B to date. The study showed that rFIXFc provides long-lasting protection from bleeding with fewer injections than are required with the current standard of care. The company'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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