The Food and Drug Administration revealed Wednesday that for the first time an anti-clotting drug made from the milk of genetically engineered goats works and its safety is acceptable.

 

The drug is called ATryn and belongs to a Massachusetts biotechnology company, GTC Biotherapeutics. It 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.

 

“It's a new mechanism by which drugs could be produced in pretty large volume in the future,” said Dr. Stephan Moll, a hematologist at the University of North Carolina, Chapel Hill, who consults for the company.

 

The drug is designed to help people with a rare hereditary disorder that makes them vulnerable to life-threatening blood clots. It is used during surgery and childbirth. Dr. Moll is also a top medical adviser to the National Alliance for Thrombosis and Thrombofilia, a group that represents patients with the blood disorder.

 

On Friday, a panel of outside advisers will make a recommendation to the FDA on whether the drug is safe and effective. The agency usually takes their advices.

 

If approved, it 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.