FDA Advisory Committee Recommends
GTC Biotherapeutics' ATryn*(antithrombin [Recombinant])
If approved, ATryn will be first recombinant human antithrombin available in the U.S.
Rockville, Md., January 9, 2009 – GTC Biotherapeutics ("GTC", NASDAQ: GTCB) and OVATION Pharmaceuticals, Inc. announced today that the Blood Products Advisory Committee of the U.S. Food and Drug Administration (FDA) voted that ATryn is safe and efficacious for the prevention and treatment of venous thromboembolism in hereditary antithrombin deficient patients undergoing surgery or childbirth procedures. The FDA considers the recommendations of its Advisory Committees when making its determinations. If approved, ATryn will be the first recombinant human antithrombin available in the U.S.
“We are very pleased with the Advisory Committee’s recommendation in support of the safety and efficacy of ATryn,” saidGeoffrey F. Cox, Ph.D., GTC’s Chairman and Chief Executive Officer. “ATryn is the first transgenically produced therapeutic to achieve approval in Europe and undergo review by the FDA. ATryn is also a testament to our established strength in recombinant technology, and has the potential to provide an important new treatment option for patients with hereditary antithrombin deficiency.”
In September 2008, the FDA assigned Priority Review to GTC’s Biologic License Application, or BLA, for ATryn. Priority Review is granted to applications for products that, if approved, would provide significant advances in treatment or provide a treatment where no sufficient one already exists. Under Priority Review, the FDA’s target date for action on the BLA is February 7, 2009. GTC has licensed ATryn to OVATION to develop and market it in the U.S.
"The committee’s recommendation takes us a step closer to making ATryn available to people in the U.S. with hereditary antithrombin deficiency, a rare clotting disorder associated with severe complications for which there are few treatment options," said Jeffrey S. Aronin, OVATION President and Chief Executive Officer. “Consistent with our overall focus on addressing unmet medical needs of small patient populations, bringing ATryn to market would give us the opportunity to make a meaningful difference in the lives of people suffering from this rare disorder.”
Antithrombin works as a natural anticoagulant in the human body by regulating thrombin, which plays an important role in controlling the formation of blood clots.ATryn was developed with the key objective to provide the purity, safety and consistency of an unlimited supply of recombinant antithrombin. Purified recombinant antithrombin has the same amino acid sequence as antithrombin derived from human plasma.
People with hereditary antithrombin deficiency are at increased risk for venous blood clots, including pulmonary embolism and deep vein thrombosis. The prevalence of
hereditary antithrombin deficiency in the general population is approximately one in 2,000 to one in 3,000.Half these patients may experience a thrombosis before 25 years of age and based on one study, up to 85 percent may suffer a thromboembolic event by age 50.
About ATryn*(antithrombin [Recombinant])
ATryn is the first recombinant antithrombin product approved in the world and the first antithrombin product that has been approved through the centralized European Medicines Agency (EMEA) procedure in the European Union.
ATryn is under review by the FDA for the prevention and treatment of peripartum and perioperative thromboembolic events in patients with hereditary antithrombin deficiency.
The most common adverse events listed in the approved European labeling that may occur during ATryn treatment include dizziness, headache, bleeding, nausea, bleeding at injection site and increased bleeding during treatment.As with any intravenous protein product, allergic type hypersensitivity reactions are possible.