Eideard

The first drug made using genetically engineered animals to near U.S. approval has won key support from an advisory panel that judged it safe and effective…

GTC Biotherapeutics experimental anticlotting therapy, called Atryn, is made using a human protein gathered from female goats bred to produce it in their milk. GTC is seeking approval to sell the intravenous therapy to prevent excessive blood clots in patients with an inherited disorder.

“This will… set a precedent for what will happen in the future,” said Dr. Richard Colvin, the panel’s consumer representative.

The FDA issued preliminary guidelines in September about how it would regulate animals whose DNA has been altered and called for public comment, but it has not yet issued final details.

Some parts of the Vegetarian Left oppose transgenic animals altogether. They will marshall whatever they can to delay processes like this.

Still, FDA officials said they were seeking advice on the specific product, not the larger issue of genetically-altered animals. They added that the final regulations on such animals would be released soon.

Several patients and family members at the advisory meeting urged the FDA’s approval of Atryn regardless of the transgenic issue.

Karen Janes, whose daughter died after a 7-inch-long clot, said it could help her remaining daughter live longer and have children. “I don’t care how it’s made,” the New Mexico resident told the panel.

Between 60,000 and 600,000 people in the United States have the excessive clotting disorder, known as hereditary antithrombin deficiency, according to GTC.

RTFA. That doesn’t invalidate the fears. It’s the role of the producer and government bodies – who I don’t trust a hell of a lot either – to sort that out. If you can do better. Offer it up. It’s always a political question.

UPDATE: Approved by the FDA, today, 6 February.