FDA approves Biogen Idec's Eloctate

FDA approved a BLA for Eloctate (rFVIIIFc) from Biogen Idec Inc. (NASDAQ:BIIB) to control and prevent bleeding episodes, for perioperative management and for routine prophylaxis in adults and children with hemophilia A. Biogen Idec said it plans to launch the product in the U.S. next month, but has not yet determined pricing. Eloctate is a long-acting recombinant fusion protein consisting of the Fc domain of human IgG1 attached to Factor VIII. The company plans to submit an MAA to EMA next half. ...