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Swedish Orphan Biovitrum announces first regulatory approval worldwide for Alprolix


Friday, 21 Mar 2014 08:04am EDT 

Swedish Orphan Biovitrum publ AB (Sobi):Says Health Canada approves Alprolix (Coagulation Factor IX (Recombinant), Fc fusion protein), rFIXFc, for the control and prevention of bleeding episodes and routine prophylaxis in adults, and children aged 12 and older, with haemophilia B.Health Canada decision was announced by Sobi partner, Biogen Idec.The approval is based on results from the global, phase 3 B-LONG study demonstrating that Alprolix safely and effectively prevented, or reduced, bleeding episodes with prophylactic injections given once weekly or once every 10-14 days in adults and adolescents with severe haemophilia B.This is the first regulatory approval worldwide for Alprolix. 

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