EU approves Alprolix (rFIXFc) for the treatment of haemophilia B- Swedish Orphan Biovitrum/Biogen

Swedish Orphan Biovitrum and Biogen have announced that the European Commission 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 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. Alprolix is indicated for both on-demand and prophylaxis treatment of people with haemophilia B in all ages. 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.

The EC’s approval of Alprolix was based on results from two global Phase III clinical trials that demonstrated the efficacy, safety and pharmacokinetics of Alprolix for haemophilia B: the pivotal B-LONG study for previously treated adults and adolescents, and the Kids B-LONG study for previously treated children under age 12. The adverse drug reactions with an incidence of at least 0.5 percent for Alprolix were nasopharyngitis (common cold), influenza, arthralgia (joint pain), upper respiratory tract infection, headache, and hypertension. The majority of these events were judged as not related or likely not related to study drug.

Comment: Comment: Alprolix is also approved in the US, Canada , Australia and Japan for the control and prevention of bleeding episodes and routine prophylaxis in adults, and children aged 12 and older, with haemophilia B. Alprolix is the first approved long-acting haemophilia B therapy and is indicated to prevent or reduce the frequency of bleeding episodes with prophylactic injections scheduled once weekly or once every 10-14 days.