Biogen Idec files for Elocta approval in Europe

10 October 2014

US biotech firm Biogen Idec (Nasdaq: BIIB) has submitted a Marketing Authorization Application (MAA) for Elocta (rFVIIIFc; recombinant factor VIII Fc fusion protein) to the European Medicines Agency.

Swedish Orphan Biovitrum (STO: SOBI) has an exclusive opt-in right to assume final development and commercialization of Elocta in Europe, Russia, the Middle East and Northern Africa.The MAA filing with the EMA triggers the formal opt-in right, giving SOBI around two months to exercise its option.

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

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