September 4, 2008
GTC Drug Granted FDA Priority Status
By Matthew L. Brown
Framingham-based GTC Biotherapeutics Inc. says the U.S. Food and Drug Administration has granted the biologic license application for the company's key product priority review status.
The FDA grants priority review to products that, if approved, could present a significant improvement in the safety or effectiveness of the treatment and diagnosis of diseases. GTC's ATryn, an anti-clotting treatment based on a protein developed in the milk of genetically modified goats, may be approved within six months under the priority review.
GTC intends ATryn to be used in patients with hereditary anti-clotting deficiencies who are undergoing high-risk surgeries or childbirth.
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