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General Health : Drug News Last Updated: Apr 20, 2011 - 9:38:09 AM

FDA approves genetically engineered drug
By Jimmy Downs
Feb 8, 2009 - 11:04:15 AM

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Feb 8, 2009 ( -- The Food and Drug Administration has for the first time in history approved a drug produced by a genetically engineered animal, the associated press reported on Friday.


The drug called ATryn is harvested from the milk produced by a genetically engineered goat. The animal has been so genetically modified that it produces a higher level of antithrombin, a protein that acts as a blood thinner.


About 1 in 5000 people suffer a genetic disorder and are not able to produce enough antithrombin protein, GTC Biotherapeutics, the manufacturer of ATryn, was cited as saying. These people are at high risk of deadly blood clots. Pregnant women with the disorder are at high risk of having stillbirth or miscarriage.


Treatment of the disorder currently relies on conventional blood thinners such as Plavix from Bristol-Myers Squibb and Sanofi-Aventis, the AP reported.


But the new biotech drug is not in a position to replace the conventional blood thinners.   ATryn is indicated only for use in patients who are at high risk of blood clots such as those undergoing surgery and pregnant women with the genetic disorder.

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