U.S. FDA OKs first drug from DNA-altered animals

WASHINGTON, Feb. 6 (Chinese media) -- The U.S. Food and Drug Administration (FDA)

on Friday approved the first drug made using genetically engineered animals,

clearing the way for a new class of medical therapies.

The drug, GTC Biotherapeutics Inc's anti-clotting therapy Atryn, is an

intravenous therapy made using a human protein gathered from female goats that

have been scientifically altered to produce extra antithrombin, a protein that

acts as a natural blood thinner.

Atryn aims to prevent excessive blood clots in patients with a disorder

known as hereditary antithrombin deficiency. The Framingham, Mass.-based company

estimates the disorder affects anywhere from 60,000 to 600,000 people in the

United States.

People with hereditary antithrombin deficiency are at increased risk for

venous thromboembolic events, including pulmonary embolism and deep vein

thrombosis, which can be life-threatening, particularly in high risk situations.

The FDA approved Atryn to prevent blood clots from surgery or childbirth in

patients with the condition, but not wider use to treat the disorder itself, the

company said in a statement.

"The approval of ATryn marks a significant milestone in the development of

this innovative recombinant technology and delivers a new therapeutic option to

benefit hereditary antithrombin deficient patients who are undergoing surgery or

childbirth procedures," said Geoffrey F. Cox, GTC's Chairman and Chief Executive

Officer.

The drug's approval may be the first step toward new kinds of medications

made not from chemicals, but from living organisms altered by

scientists.