Sobi and Biogen's Elocta Approved by EC for Treatment of Haemophilia A

Swedish Orphan Biovitrum AB

and Biogen

today announced that the European Commission (EC) has approved Elocta® (rFVIIIFc) for the treatment of haemophilia A in all 28 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. Elocta, a recombinant factor VIII Fc fusion protein with an extended half-life, will be the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days. "The EC's approval of Elocta is an important milestone for the global haemophilia A community, offering the potential to improve the care of haemophilia A across the EU," said Birgitte Volck, M.D., Ph.D., senior vice president of Development and chief medical officer of Sobi. "Our focus is now to ensure timely and sustainable access to Elocta for people living with haemophilia A throughout Europe." Elocta is indicated for both on-demand and prophylaxis treatment of people with haemophilia A of all