Eloctate RFVIIIFc regulatory update

EMA accepted for review a MAA from Biogen Idec for Elocta to treat hemophilia A. The long-acting recombinant fusion protein consisting of the Fc domain of human IgG1 attached to Factor VIII has Orphan Drug designation in the EU for the indication. It is approved as Eloctate in the U.S., Canada and Australia. ...