FDA approves GTC’s transgenic drug ATryn (FierceBiotech)
February 9, 2009 — 9:37am ET |
By Maureen Martino
The FDA has approved GTC Biotherapeutics’ ATryn. This marks the first time the agency has given the okay to a transgenic therapy–a drug developed in genetically engineered animals–and the first recombinant antithrombin approved in the U.S. ATryn, which is made from the milk of genetically engineered goats, will be used for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. GTC and Ovation, which will market the drug in the U.S., expect ATryn to be available in the second quarter of 2009.
FDA’s Center for Veterinary Medicine also approved GTC’s New Animal Drug Application, the first of its kind to regulate genetically engineered animals. The application will now be required for all therapies develop using transgenic animals.
“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 GTC’s Chairman and CEO Geoffrey Cox. “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.”
FDA staffers endorse transgenic anti-clotting drug
GTC shares jump on $257M ATryn pact
GTC announces positive ATryn data
GTC inks new transgenics collaboration deal
Regulators focusing on transgenic animals