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Swedish Orphan Biovitrum AB (publ) (Sobi™) and Biogen announced that the European Commission (EC) has approved Alprolix® (rFIXFc), their extended half-life therapy, for the treatment of haemophilia B in all 28 European Union (EU) member states and maintained its orphan designation. Alprolix is indicated for both on-demand and prophylaxis treatment of people with haemophilia B in all ages.
Alprolix is the only recombinant factor IX Fc Fusion protein therapy for haemophilia B to offer people in the EU prolonged protection against bleeding episodes with fewer prophylactic injections.Prophylactically, it can be administered with an initial dose every seven days or every 10 days with the ability to adjust the dosing interval based on individual response.
“With the approval of Alprolix, people with haemophilia B in Europe now have the potential to experience prolonged protection from bleeds with fewer injections,” said Krassimir Mitchev, M.D., Ph.D., vice president and medical therapeutic area head of Haemophilia at Sobi. “We are working to make Alprolix available in Europe as quickly as possible. Along with Biogen, we’re excited to continue offering innovative therapies to people with haemophilia around the world.”
