December 10, 2007
GTC Obtains Orphan Status For ATryn
By Cory Hopkins
Framingham biotechnology company GTC Biotherapeutics Inc. announced today that the FDA has granted orphan status to its ATryn drug treatment for patients with hereditary antithrombin deficiency, or HD.
Orphan status provides GTC with seven years of marketing exclusivity upon product licensure, as well as an automatic waiver of the FDA's application user fee, the company said.
ATryn is a recombinant form of an anticoagulant and anti-inflammatory human protein produced in the milk of goats, the company said.
The Orphan Drug Act is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 patients in the United States.
Orphan status provides GTC with seven years of marketing exclusivity upon product licensure, as well as an automatic waiver of the FDA's application user fee, the company said.
ATryn is a recombinant form of an anticoagulant and anti-inflammatory human protein produced in the milk of goats, the company said.
The Orphan Drug Act is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 patients in the United States.
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