An advisory panel to the FDA is recommending approval of the first US drug made with help from genetically engineered animals. GTC Biotherapeutics makes Atryn, an anti-clotting therapy, using a herd of 200 goats bred to express a human protein in their milk. The drug is meant to help people with hereditary antithrombin deficiency, a genetic disorder that causes blood clotting. Patients and their families want the drug approved and say studies show it's safe and effective. But other folks argue that there hasn't been enough safety testing around the use of transgenic animals. The final FDA decision is expected February 7.
The FDA approved ATryn this afternoon.
And despite the lingering controversy over potential environmental and safety concerns, the drug is expected to earn $40-50 million for its maker in its first five years on the US market.
Interestingly, ATryn has been licensed for use in Europe--where public resistance to GMOs tends to be higher--since 2006.
The FDA approved ATryn this afternoon.
And despite the lingering controversy over potential environmental and safety concerns, the drug is expected to earn $40-50 million for its maker in its first five years on the US market.
Interestingly, ATryn has been licensed for use in Europe--where public resistance to GMOs tends to be higher--since 2006.
how cool is that? I think they should go for it, and release it...
ohh...so it was released allready?? thats gud..
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