US biotech firm Biogen Idec submits Marketing Authorization Application for Elocta in Europe

Monday, October 13, 2014

Swedish Orphan Biovitrum AB quoted that Biogen Idec has posted a Marketing Authorisation Application (MAA) for Elocta to the European Medicines Agency (EMA). Sobi has an exclusive opt-in right to presume development and commercialization of Elocta in Europe, Russia, the Middle East and Northern Africa.


Elocta is a long-acting recombinant factor VIIIFc fusion protein product candidate for people with haemophilia A. Elocta is the approved European trade name for rFVIIIFc, also known as Eloctate(TM) in the U.S., Canada, and Australia, where it is approved for the treatment of hemophilia A.