Baxter Announces Successful Phase 3 Study
Health-care company Baxterannounced in a press release Tuesday that its phase 3 trial of hemophilia treatment FEIBA NF successfully showed significant reduction in bleeding among patients. The company plans to use the study as part of a biologics license application (BLA) to the FDA sometime in 2013's first quarter.
According to the study results, routine prophylaxis treatment with FEIBA NF reduced median annual bleed rates by more than 72% among the patient population, as compared with using the treatment on demand. Baxter's release states that up to a third of patients with hemophilia develop inhibitors to treatments -- a problem that an anti-inhibitor coagulant like FEIBA NF could combat.
Baxter's bioscience business vice president of global research and development, Prof. Hartmut J. Ehrlich, explained the company's goal with the treatment, saying:
One of the greatest remaining challenges in the management of hemophilia is the development of inhibitors, which can lead to more difficult-to-control and sometimes life-threatening bleeding. The FEIBA NF prophylaxis study demonstrates Baxter's dedication to providing treatment options to the hemophilia community, including effective inhibitor management.
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