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Baxter International Inc announces positive top-line results from Its phase 3 study of BAX 855, extended half-life recombinant FVIII for hemophilia a patients


Thursday, 21 Aug 2014 09:00am EDT 

Baxter International Inc:Announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)].Met its primary endpoint in reducing annualized bleed rates (ABR) in the prophylaxis arm compared to the on-demand arm.Top-line results from the prospective, global, multi-center Phase 3 study demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older.Patients in a twice-weekly prophylaxis arm experienced a 95 percent reduction in median ABR as compared to those in the on-demand arm.BAX 855 was also effective in treating bleeding episodes, 96 percent of which were controlled with one or two infusions. 

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67.94
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