EMA Advisory Committee Recommends Biogen’s Hemophilia B Drug

Swedish Orphan Biovitrum AB (Sobi) and Biogen have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending that marketing authorization be granted for Alprolix (rFIXFc), a recombinant factor IX Fc fusion protein therapy for the treatment of hemophilia B.

Sobi and Biogen are collaborators in the development and commercialization of Alprolix for hemophilia B. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Biogen leads development and manufacturing for Alprolix and has commercialization rights in North America and all other regions in the world excluding the Sobi territory.

Source: Biogen

Leave a Reply

Your email address will not be published. Required fields are marked *