Health Canada approves Biogen Idec’s long-acting Alprolix hemophilia B
US biotech firm Biogen Idec (Nasdaq: BIIB) has announced that Health Canada has approved Alprolix (coagulation Factor IX [recombinant], Fc fusion protein), for the control and prevention of bleeding episodes and routine prophylaxis in adults, and children aged 12 and older, with hemophilia B.
Alprolix, under development with Swedish Orphan Biovitrum (STO: SOBI), is the first approved long-acting hemophilia B therapy and is indicated to prevent or reduce the frequency of bleeding episodes with prophylactic (protective) infusions starting at once weekly or once every 10-14 days. This is the first regulatory approval worldwide for Alprolix, which is currently under review by regulatory authorities in several other countries, including the USA (where the Food and Drug Administration has delayed approval (The Pharma Letter December 2, 2013), Australia and Japan.
Significant advance
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