U.S. Approves First Drug From DNA-Altered Animals

Shares of the Framingham, Massachusetts-based company were down nearly 9 percent to 75 cents in afternoon trade on Nasdaq.

 U.S. health officials on Friday approved the first drug made using genetically engineered animals, amid lingering concerns about genetic implications.

The drug, GTC Biotherapeutics Inc's anti-clotting therapy Atryn, is an intravenous therapy made using a human protein gathered from female goats specially bred to produce it in their milk.

Atryn aims to prevent excessive blood clots in patients with a disorder known as hereditary antithrombin deficiency. The company estimates the disorder affects anywhere from 60,000 to 600,000 people in the United States.

The Food and Drug Administration 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.

GTC had been seeking approval for both uses, and earlier predicted the drug could generate $40 million to $50 million in annual sales in the United States in its first five years on the market.

"The approval of Atryn marks a significant milestone in the development of this innovative recombinant technology," GTC Chairman and CEO Geoffrey Cox said in a statement.

But some genetic-safety and animal advocates have raised doubts about using so-called transgenic animals to make pharmaceuticals, saying the FDA needs to provide more information about genetically engineered animals.

The FDA last month issued final guidelines on its plans to regulate animals whose DNA has been altered. It has yet to approve a genetically-engineered animal for human consumption. Agency officials said they aimed to make the regulatory process more transparent, but some critics said they did not go far enough.

Jaydee Hanson, a policy analyst for the nonprofit group Center for Food Safety, said treating GTC's goats as a drug rather than as an animal left many questions unanswered, such as what would happen to the goats that die. Dead animals are sometimes processed for pet food.

"This is a backdoor way to approve genetically engineered animals," Hanson told Reuters.

GTC's goats are bred using cells injected with human DNA. The company has a herd of about 200 at its Massachusetts facility. The company says the heard is otherwise normal and healthy.

The drug is licensed to Ovation Pharmaceuticals Inc in the United States and should be available by the second quarter this year, the company said.

Shares of the Framingham, Massachusetts-based company were down nearly 9 percent to 75 cents in afternoon trade on Nasdaq.