U.S. panel backs first drug from DNA-altered animals

By Susan Heavey

ROCKVILLE, Maryland (Reuters) - A U.S. advisory panel recommended approval of what would be the first drug made using genetically engineered animals on the U.S. market, saying it appeared safe and effective despite concerns heard from groups worried about the genetic tinkering.

The product, GTC Biotherapeutics Inc''s experimental anticlotting therapy Atryn, is made using a human protein from female goats engineered 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 clotting disorder.

Company data showed the drug was safe and effective, the majority of the Food and Drug Administration''s 19-member panel said on Friday. The FDA will weigh the recommendation as it decides whether to approve the product. A decision is expected by February 7.

"This will ... set a precedent for what will happen in the future," said Dr. Richard Colvin, the panel''s consumer representative and a clinical assistant in medicine at Massachusetts General Hospital.

But some genetic-safety and animal advocates at the meeting expressed concern about the use of such so-called transgenic animals despite the drug''s benefits, saying more information is needed from the agency about genetically engineered animals overall.

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.

Approving Atryn "would be a back door way to approve transgenic animals," said Jaydee Hanson, a policy analyst for the nonprofit group Center for Food Safety.

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

Atryn is made from human protein produced in milk from genetically engineered goats bred using cells injected with human DNA, according to GTC. Females then express the human anti-clotting protein in their milk.

The drug is licensed to Ovation Pharmaceuticals Inc in the United States.

(Editing by Tim Dobbyn)