FDA Advisory Committee Backs Drug From Engineered Goat

By Anna Boyd
17:01, January 10th 2009
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FDA Advisory Committee Backs Drug From Engineered Goat

An advisory committee of the Food and Drug Administration recommended on Friday the approval of Atryn, the first anti-clogging drug made from milk of genetically engineered goats.

The drug belongs to a Massachusetts biotechnology company, GTC Biotherapeutics. and was obtained by altering the genes of goats so they would produce milk rich in antithrombin, a protein that in humans acts as a natural blood thinner.

The drug is designed to help people with a rare hereditary disorder antithrobin deficiency, which makes them vulnerable to life-threatening blood clots. Current treatment involves taking blood thinners and infusions of human antithrombin, extracted from donated blood.

According to GTC, Atryn was tested in men and women with the condition: some of them were pregnant and other had recently had surgery. The drug proved safe and effective, but there is not enough data regarding its use.

However, the FDA advisory committee recommended Atryn be approved, but the company should do postmarketing safety studies. The FDA now will consider the advisory’s opinion, but it’s not obligated to follow its recommendation.

If approved, Atryn would be for the first time when a medication is made not from chemicals, but from living organism genetically manipulated by scientists. Similar drugs could be available in the next few years for a range of human ailments, including hemophilia.

GTC is also planning studies to test the drug in patients at risk for clots in non-hereditary conditions such as coronary bypass surgery, which if approved later by the FDA could boost sales, said Geoffrey Cox, chairman of GTC.

 



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