FDA Announces First Human Drug from Genetically Engineered Animals May 4, 2009
FDA recently approved the first biological product made from genetically engineered animals. The product, called ATryn, is an anticoagulant used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency. These patients can develop blood clots during high-risk situations such as surgery and childbirth. The approval gives patients with this disease an important new treatment option.
ATryn is a therapeutic protein made from the milk of genetically engineered goats. These goats have had a segment of DNA introduced into their genes that causes the female goats to produce human antithrombin in their milk. FDA's approval prohibits using these animals for food or feed, and also ensures that the genetic modification is not harming the animals. The manufacturer will continue to monitor the product's safety, including the possible development of immune responses in patients who receive repeated ATryn treatments. The product is expected to be available in the second quarter of 2009.