Biogen and Swedish Orphan Biovitrum AB (Sobi) report that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) of Alprolix (rFIXFc), a recombinant factor IX Fc fusion protein product candidate for the treatment of hemophilia B. This validation signifies the initiation of the EMA's review process.

Alprolix is a recombinant, clotting factor IX therapy and is currently approved for the treatment of hemophilia B in the US, Canada, Japan, and Australia. Biogen and Sobi are collaborators in the development and commercialization of Alprolix for hemophilia B. Sobi has an opt-in right to assume final development and commercialization of Alprolix for the Sobi territories (essentially, Europe, North Africa, Russia and certain Middle Eastern markets). Biogen leads development for Alprolix, has manufacturing rights, and has commercialization rights in North America and all other regions in the world excluding the Sobi territories.

Source: Biogen