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Baxter International Inc receives FDA approval for FEIBA

Thursday, 19 Dec 2013 09:00am EST 

Baxter International Inc:Says that the United States Food and Drug Administration (FDA) granted approval for FEIBA [Anti-Inhibitor Coagulant Complex].Says the approval is based on data from a pivotal Phase III study, known as FEIBA PROOF, in which treatment with a FEIBA prophylactic regimen showed a 72 pct reduction in median annual bleed rate (ABR) compared to treatment with an on-demand regimen.Says in the intent-to-treat (ITT) analysis, three of the 17 (18%) adult patients in the prophylactic arm reported no bleeding episodes.Says most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.Says serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis. 

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20 Oct 2014