FDA delays Biogen Idec's hemophilia B product

Biogen Idec Inc. (NASDAQ:BIIB) said FDA extended by three months the PDUFA date for a BLA for Alprolix rFIXFc to treat hemophilia B. According to the company, the delay was due to the submission of additional information on the validation of a manufacturing step for the recombinant fusion protein consisting of human coagulation Factor IX attached to the Fc domain of human IgG1. Biogen Idec submitted the BLA in 4Q12; the new and original PDUFA dates are not disclosed.

Biogen Idec also has a product under review in the U.S. for hemophilia A. Last month, the company disclosed on a conference call to discuss its 3Q13 earnings that it also expects FDA to delay its review of that product -- Eloctate rFVIIIFc, a long-acting recombinant fusion protein consisting of the Fc domain of human IgG1 attached to Factor VIII. Biogen Idec submitted a BLA for Eloctate in March, but the PDUFA date is not disclosed. ...