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FDA Grants Priority Review on Recombinant Form of Human Antithrombin
“We are pleased that the FDA has recognized the inherent advantage of ATryn as the only recombinant antithrombin product that may become available to patients with hereditary antithrombin deficiency who are at risk of developing serious or potentially life-threatening venous thromboembolic events,” stated Geoffrey F. Cox, PhD, GTC’s Chairman and CEO. “We look forward to continuing our collaborative efforts with the FDA during the review process.”
The FDA’s goal for completing review of applications assigned Priority Review is six months from receipt of the complete application. GTC filed the last section of the BLA on August 7, 2008.
ATryn is GTC’s recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The BLA seeks a license to sell ATryn in the United States for the prophylactic treatment of deep vein thrombosis and other thromboembolisms in patients with hereditary antithrombin deficiency who are undergoing high risk surgical and childbirth procedures. There are no other recombinant forms of antithrombin available to treat this rare patient population. GTC has licensed ATryn to OVATION Pharmaceuticals, Inc. to develop and market it in the United States.
Source: GTC Biotherapeutics