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news.GTC Biotherapeutics, a developer of human therapeutic proteins, and Ovation Pharmaceuticals, have received the FDA approval for ATryn for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.
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ATryn is said to be the first ever transgenically produced therapeutic protein and the first recombinant antithrombin approved in the US. It is now also the first recombinant antithrombin product approved by the FDA, the two companies said.
Along with the approval of ATryn, the FDA’s Center for Veterinary Medicine also approved GTC’s new animal drug application, the first of its kind to regulate genetically engineered animals. GTC has granted Ovation the right to market ATryn in the US and pursue further clinical development. The companies expect ATryn to be available in the second quarter of 2009.
Geoffrey Cox, chairman and CEO of GTC Biotherapeutics, said: 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.
GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. In addition to ATryn, GTC has a pipeline portfolio of recombinant human plasma proteins. These proteins include recombinant forms of human coagulation factors VIIa, VIII, and IX, which are being developed for the treatment of hemophilia, and alpha-1 antitrypsin.