Saturday, February 7, 2009

FDA Approves ATryn

Have you heard of ATryn? No, that's not a typo. It's an anti-coagulant used for patients with hereditary antithrombin (AT) deficiency. ATryn is made by GTC Biotherapeutics, Inc.

ATryn is unique in that it is the first FDA approved drug made by genetically engineered (GE) animals. So if we're genetically engineering animals, do you think anyone's genetically engineering any humans? Both the Center for Biologics Evaluation and Research (CBER) approved this agent based on its safety and efficacy and the Center for Veterinary Medicine (CVM) approved the rDNA construct in the goats that produce ATryn.

ATryn has an orphan drug designation by the FDA since hereditary antithrombin (AT) deficiency is so uncommon.

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