The European Commission has approved Elocta (rFVIIIFc) for the treatment of hemophilia A in all 28 European Union member states, as well as Iceland, Liechtenstein and Norway.
Elocta, a recombinant factor VIII Fc fusion protein with an extended half-life, developed by Swedish Orphan Biovitrum (STO: SOBI) and US biotech firm Biogen (Nasdaq: BIIB), will be the first hemophilia 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 hemophilia A community, offering the potential to improve the care of hemophilia A across the EU," said Birgitte Volck, senior vice president of development and chief medical officer of Sobi, adding: "Our focus is now to ensure timely and sustainable access to Elocta for people living with hemophilia A throughout Europe."
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