ATryn is the first transgenically produced therapeutic protein and the first recombinant antithrombin approved in the U.S. Also, the FDA’s Center for Veterinary Medicine approved GTC’s New Animal Drug Application, the first of its kind to regulate genetically engineered animals. This is now required for a recombinant technology used to develop transgenic animals, such as goats that produce recombinant antithrombin. GTC has granted Ovation the right to market ATryn in the U.S. and pursue further clinical development. The companies expect ATryn to be available in 2Q09.
People with hereditary antithrombin deficiency are at increased risk for venous thromboembolic events, including pulmonary embolism and deep vein thrombosis, which can be life-threatening, particularly in high risk situations. Antithrombin is a natural anticoagulant that plays an important role in controlling the formation of blood clots. Purified recombinant antithrombin has the same amino acid sequence as antithrombin derived from human plasma.
“The approval of ATryn marks a significant milestone in the development of this innovative recombinant technology and delivers a new therapeutic option to benefit hereditary antithrombin deficient patients who are undergoing surgery or childbirth procedures,” said Geoffrey F. Cox, Ph.D., GTC’s chairman and chief executive officer. “Advancing this novel technology from the early days of demonstrating its capability to the daily practice of producing a safe and efficacious product for the U.S. and the European Union, is a testament to the persistence and capability of our employees.”