FDA Assigns Priority Review to GTC Biotherapeutics' ATryn(R)
Thursday September 4, 8:00 am ET
FRAMINGHAM, Mass.--(BUSINESS WIRE)--The US Food and Drug Administration, or FDA, has assigned Priority Review to GTC Biotherapeutics, Inc.’s ("GTC", Nasdaq: GTCB) Biologic License Application, or BLA, for ATryn®. Priority Review is granted to applications for products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Under Priority Review, the FDA’s target date for action on the BLA is February 7, 2009.
“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.
