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GTC’s goat milk-derived ATryn approved

Executive Summary

FDA approves the first therapeutic protein derived from a genetically engineered animal Feb. 6. GTC Biotherapeutics' ATryn (recombinant antithrombin III) received approval from both CBER and the Center for Veterinary Medicine to treat patients with the rare clotting disease hereditary antithrombin deficiency. ATryn is the first recombinant antithrombin approved in the U.S. The approval was also a first for CVM - this is the first genetically engineered animal construct to clear FDA, opening the door for future GE animal products in development. Although advisory committee members voted unanimously that a post-marketing study should be conducted to assess the risk/benefit profile after repeat dosing of ATryn, FDA did not mention any required studies in its press release (1"The Pink Sheet," Jan. 19, 2008, p. 27). GTC stated in its announcement that post-marketing studies will be performed to assess safety and immunogenicity after repeat dosing. ATryn should be available by the second quarter, GTC said

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