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Support for drug made from DNA-altered animals

(Agencies)
Updated: 2009-01-12 07:33

The first drug made using genetically engineered animals to near US approval won key support on Friday from an advisory panel that judged it safe and effective despite concerns from groups worried about the genetic tinkering.

GTC Biotherapeutics Inc's experimental anti-clotting 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. Between 60,000 and 600,000 people in the US have the excessive clotting disorder, known as hereditary antithrombin deficiency, according to GTC.

Company data showed the drug was safe and effective, a majority of the Food and Drug Administration's 19-member panel voted. The FDA will consider the advice in making its decision, expected by Feb 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 so-called transgenic animals despite the drug's benefits, saying more information is needed about genetically engineered animals.

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 non-profit group Center for Food Safety.

Still, FDA officials said they were seeking advice on the specific product, not the larger issue of generically-altered animals.

The goats used to make Atryn are bred using cells injected with human DNA. The company has a herd of about 200 at its Massachusetts facility, which are otherwise normal and screened for viruses, GTC said.