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17 Oct 2015

Health Canada approves Baxalta’s Obizur to treat bleeding episodes in patients with acquired haemophilia A

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Baxalta Incorporated, a global biopharmaceutical leader, announced that Health Canada has approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in patients with acquired haemophilia 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 haemophilia A, specifically designed to enable physicians to monitor treatment response by measuring FVIII activity levels in addition to clinical assessments.

“The approval of Obizur in Canada provides physicians with an important new and effective treatment for acquired haemophilia A,” said Dr. Jean St-Louis, hematologist at Hôpital Maisonneuve-Rosemont and associate professor at Université de Montréal.

“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.”

The approval is supported by the positive results of a global, prospective, controlled, multi-center phase II/III open-label clinical trial that examined the efficacy of Obizur in the treatment of serious bleeding episodes in patients with acquired haemophilia A. All patients treated with Obizur, 100 per cent (28/28), showed a positive response and clinical improvement at 24 hours after the initial infusion. Successful control (resolution) of the initial bleeding episode was observed in 86 percent (24/28) of all patients and in 94 per cent (16/17) of those treated with Obizur as the first-line treatment. The development of antibodies to porcine FVIII was the only adverse reaction reported in more than five percent of patients.

“As the first recombinant porcine option for acquired hemophilia in Canada, Obizur offers a significant advancement for physicians treating this challenging disease by allowing them to monitor levels of FVIII activity and adjust based on their patient’s response to the treatment,” said Brian Goff, executive vice president and president, haematology, Baxalta.

“We look forward to introducing this treatment for the hemophilia community in Canada and continuing our efforts to reduce the burden of bleeding disorders as we pursue a world without bleeds.”

Obizur is now approved in the United States and Canada, and is under regulatory review in the European Union, Switzerland, Australia and Colombia.

The most frequently reported adverse drug reactions (ADRs) included constipation, diarrhea, hypokalemia, anemia, oedema peripheral and a positive anti-porcine inhibitor test result.

Non-serious Adverse Reactions occurred in 6.9 per cent of subjects, these 2 subjects developed anti-porcine FVIII inhibitors.

Acquired haemophilia A is a rare, life-threatening bleeding disorder, which, unlike congenital hemophilia, typically affects older adults and occurs in both males and females. In acquired haemophilia A, individuals typically experience subcutaneous, soft tissue, and post-surgical bleeding. The comorbidities in this typically elderly population also pose a particular challenge to treat serious bleeding episodes.

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