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GTC antithrombin ATryn assigned priority review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA assigns priority review to GTC Biotherapeutics' antithrombin ATryn, firm says Sept. 4. The BLA's target user fee date is Feb. 7, 2009. GTC filed the final portion of the rolling BLA for ATryn Aug. 7 for prophylactic treatment of deep vein thrombosis and other thromboembolisms in patients with hereditary antithrombin deficiency who are undergoing high risk surgical and childbirth procedures. Ovation Pharmaceuticals has the license for development and marketing of ATryn in the U.S. The drug is already approved for antithrombin hereditary deficiency in Europe, where a Phase II trial is underway testing ATryn in disseminated intravascular coagulation associated with severe sepsis. Top-line results are due in the second half of next year

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