FDA: GTC Biotherapeutics' ATryn Appears Safe, Effective
Last update: 1/7/2009 9:28:16 AM
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--A Food and Drug Administration reviewer said Wednesday a GTC Biotherapeutics' (GTCB) product derived from the milk of genetically altered goats to treat a rare blood clotting disorder was effective.
The reviewer also said the safety profile of the product, known as ATryn, "appears to be acceptable." The review was released Wednesday ahead of an FDA panel meeting Friday on the matter.
ATryn is a form of human antithrombin, a protein present in human blood. The product is designed to treat certain patients with a rare condition known as hereditary antithrombin deficiency. Those patients don't have enough antithrobmin in their blood and are at risk of developing life-threatening blood clots. The company estimates about 1 in 2,000 to 3,000 people in the U.S. have the disorder. ATryn would be used by some pregnant women and patients undergoing surgery who cannot be on blood-thinners normally used to treat the condition.
ATryn is made from the milk of goats that were genetically engineered to produce human antithrombin, which the company says allows a steady and consistent supply of the product. Currently, one similar product can be made from human plasma but at times it has not been readily available.
Although the drug's use would initially be limited to about 100,000 patients, it's the first product derived from engineered animals pending FDA approval and lays the foundation for broader use of the technology.
The FDA panel will be asked whether it thinks ATryn is safe and effective. The FDA usually follows its panels advice but is not bound by it. ATryn was granted approval in Europe in 2006 and became available last year.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
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<reply> Have been out. Either way you are good to go. Don't be too greedy, leave some on the table for karma. :) Having problems with my mail. HNY to you too. |
