Baxter International Inc Posts Positive Results From Late Stage Hemophilia Study-Reuters


Tuesday, 8 Jan 2013 10:42am EST 

Reuters reported that Baxter International Inc reported positive results from a late-stage study evaluating routine use of its anti-inhibitor coagulant complex to treat hemophilia, a rare genetic blood clotting disorder. The data will form the basis of a biologics license application to be filed with the U.S. health regulators in the first quarter of 2013. The Phase 3 clinical trial investigated the efficacy, safety and health-related quality of life benefits of its so-called anti-inhibitor coagulant complex prophylactic treatment given to maintain health and prevent bleeds compared with on-demand treatment. The study included 36 patients with hemophilia A or B and inhibitors over a 12-month period. There was a 72.5% reduction in bleed rates for the prophylactic treatment group. The most commonly reported negative side effects in the study were hypersensitivity, dizziness, headache, rash, hypotension and hepatitis B surface antibody positive laboratory test result. 

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