Eloctate rFVIIIFc regulatory update

FDA accepted for review a BLA from Biogen Idec for Eloctate rFVIIIFc to treat hemophilia A. The company submitted the application in March; a standard review would place the PDUFA date in March 2014, though a specific date is not disclosed. Biogen Idec now has 2 hemophilia products under standard review in the U.S. A BLA for the company's Alprolix rFIXFc to treat hemophilia B also has an undisclosed PDUFA date. Biogen Idec had requested Priority Review for both applications (see BioCentury, March 11). Eloctate is a long-acting recombinant fusion protein consisting of the Fc domain of human IgG1 attached to Factor VIII, and Alprolix is a recombinant fusion protein consisting of human coagulation Factor IX attached to the Fc domain of human IgG1. ...