Biogen files MAA at EMA for Elocta (rFVIIIFc) for treatment of Haemophilia A.
Swedish Orphan Biovitrum AB announced that Biogen Idec has submitted a Marketing Authorisation Application (MAA) for Elocta (rFVIIIFc) to the European Medicines Agency (EMA). Sobi has an exclusive opt-in right to assume final development and commercialisation 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 approximately two months to exercise its option. 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 in the U.S., Canada, and Australia, where it is approved for the treatment of Haemophilia A.
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