The US Food and Drug Administration is moving closer to approval for an anti-clotting drug made from the milk of genetically engineered goats, the Associated Press reported Wednesday.
Called ATryn, the drug was developed by GTC Biotherapeutics, a Massachusetts biotech company, by altering goat genes to produce milk rich in antithrombin, a protein that acts as a natural blood thinner in humans. ATryn has already been approved in Europe, and FDA advisers are expected to meet Friday to make a recommendation on approval. The FDA will then make the final decision, the news service said.
"It's the first time we've held an advisory committee meeting on any product from a genetically engineered animal," FDA spokeswoman Siobhan DeLancey told AP. If the drug is approved, DeLancey added, the agency may require follow-up monitoring to insure patients' immune systems don't make antibodies to the medication.
About 1 in 5 000 people don't produce enough antithrombin, putting them at risk of developing painful blood clots that can break loose and travel through the bloodstream to the lungs or the brain, the AP reported. Pregnant women with the disorder are at high risk of miscarriage or stillbirth because of blood clots in the placenta.
Antithrombin has until now been produced from blood products collected from human donors, one expert told AP, but making the protein from goats may be better for humans, since it could ensure a steady supply and reduce concerns about infection.
(HealthDayNews, January 2009)
Medicine – the udder alternative