FDA approves ATryn drug extracted from genetically-engineered goat

The Food and Drug Administration (FDA) has approved ATryn - a drug from genetically-engineered goat - developed by GTC Biotherapeutics. The drug will be of immense use for surgery patients and pregnant women who have antithrombin deficiency.

According to GTC - who has given the US marketing rights of ATryn to Ovation Pharmaceuticals, Deerfield, Illinois - said that ATryn is an intravenous drug, extracted from the milk of manufactured from those genetically-engineered goats whose parents were injected human antithrombin, which is an anti-clotting protein found in healthy people.

The basis of FDA's approval of ATryn was two studies, in which 31 patients with hereditary antithrombin deficiency were administered the drug to prevent dangerous blood clots during the course of surgery or childbirth. The results that went in favor of ATryn revealed that only one of the 31 patients had a clot when treated with ATryn.

A joint statement by GTC and Ovation said that though ATryn has been approved for the deterrence of blood-clotting during the time of surgery and childbirth, in antithrombin-deficient patients, it is not a treatment of clots in such patients.

Other lines of treatment for the rare disorder, affecting nearly one person in 2,000-5,000, include intake blood thinners and infusions of human antithrombin extracted from donated human blood.

Jeffrey Aronin, CEO Ovation said ATryn would "make a meaningful difference in the lives of people with the antithrombin deficiency." (Harkiran contributed to this report)

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