BioCentury
ARTICLE | Company News

FDA to review Biogen Idec's rFVIIIFc for hemophilia A

May 14, 2013 12:26 AM UTC

Biogen Idec Inc. (NASDAQ:BIIB) said FDA accepted for review a BLA 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 two hemophilia products under review in the U.S. A BLA for the company's Alprolix rFIXFc to treat hemophilia B also has an undisclosed PDUFA date. ...