Biogen Gets EU Advisory Recommendation for Hemophilia DrugBy
Biogen and the Swedish Orphan Biovitrum AB (Sobi) have received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for the marketing authorization of Elocta (rFVIIIFc), a recombinant factor VIII Fc fusion protein product for the treatment of hemophilia A.
Biogen and Sobi are collaboration partners in the development and commercialization of the drug for hemophilia A. Last year, Sobi exercised its opt-in right to assume final development and commercialization of Eloctain the Sobi territories (essentially, Europe, North Africa, Russia and certain countries in the Middle East). Biogen leads development for the drug, has manufacturing rights, and has commercialization rights in North America and all other regions in the world excluding the Sobi territories.
Elocta is the European trade name for rFVIIIFc, which is also known as Eloctate (antihemophilic factor (recombinant), Fc fusion protein) in the U.S., Canada, Australia, New Zealand and Japan, where it is approved for the treatment of hemophilia A.