FDA priority review for GTC's Atryn

GTC Biotherapeutics' Biologic License Application for ATryn, a recombinant form of human antithrombin, has been assigned priority review status by the US Food and Drug Administration. The FDA target date for action on the BLA is February 7, 2009.

GTC seeks a license to sell ATryn in the USA 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. GTC has licensed ATryn to Ovation Pharmaceuticals to develop and market it in the USA.

"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 Cox, GTC's chief executive. "We look forward to continuing our collaborative efforts with the FDA during the review process," he added.