September 4, 2007
GTC goat gene therapy on fast track
By Matthew L. Brown
GTC Biotherapeutics Inc. said the U.S. Food and Drug Administration had put the company's ATryn on the product review fast track.
The review fast track is reserved for products that are intended to treat serious or life-threatening conditions. ATryn is an anticoagulant that GTC says can fight blood clots that are either hereditary or related to surgery or childbirth. ATryn is produced in goat's milk when goats are given a human anti-clotting gene.
The company said the FDA's review could be complete by the end of the first quarter of 2008.
ATryn has already been approved for use in Europe, and is undergoing trial testing elsewhere.
The review fast track is reserved for products that are intended to treat serious or life-threatening conditions. ATryn is an anticoagulant that GTC says can fight blood clots that are either hereditary or related to surgery or childbirth. ATryn is produced in goat's milk when goats are given a human anti-clotting gene.
The company said the FDA's review could be complete by the end of the first quarter of 2008.
ATryn has already been approved for use in Europe, and is undergoing trial testing elsewhere.
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