Baxalta’s hemophilia A drug Obizur gains approval in Canada

US pharma company Baxalta (NYSE: BXLT) says that medicines regulator Health Canada has approved its Obizur (antihemophilic Factor [recombinant], porcine sequence) for the treatment of bleeding episodes in patients with acquired hemophilia A caused by autoantibodies to coagulation Factor VIII (FVIII), a very rare and life-threatening acute bleeding disorder.

Obizur is the first recombinant porcine sequence FVIII treatment available for patients with acquired hemophilia A, specifically designed to enable physicians to monitor treatment response by measuring FVIII activity levels in addition to clinical assessments, says Baxalta, which is a spinout from Baxter International that completed on July 1, 2015.

“The approval of Obizur in Canada provides physicians with an important new and effective treatment for acquired hemophilia A," said Jean St-Louis, hematologist at Hôpital Maisonneuve-Rosemont and associate professor at Université de Montréal, Canada, adding: "This is a very challenging condition to treat and as an investigator in the clinical study, I had the opportunity to see the positive impact that Obizur can have for patients and their treating team.”