The US Food and Drug Administration today approved the first-ever drug manufactured via a genetically engineered animal, opening the door for the wider use of such methods for producing drugs in the future.

The drug, ATryn, is a protein replacement treatment for people afflicted with a rare blood-clotting disorder called hereditary antithrombin deficiency, who are at risk of thrombosis. It is made by genetically engineering goats to produce the human version of the protein in their milk.

ATryn is initially to be used by patients who cannot take blood thinners, the standard treatment for the disorder. According to a statement from GTC Biotherapeutics, the drug's manufacturer, the drug is approved "for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients."

An FDA advisory committee deemed the product safe in an independent review last month -- a required step for approving medicines made from genetically engineered animals in the US.

ATryn was approved in Europe in 2006.


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