The FDA gave the green light to the first ever transgenically produced therapeutic protein, also the first recombinant antithrombin, according to the drug's manufacturer, GTC Biotherapeutics, and its partner, Ovation Pharmaceuticals. The companies expect ATryn® to be available in the second quarter.
ATryn® (Antithrombin [Recombinant]) was approved for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.
In June, the two firms entered into a collaboration agreement to develop and market ATryn in the U.S. The agreement included $257 million in potential payments to GTC for meeting clinical, regulatory, and sales milestones.
Along with the approval of ATryn, the FDA’s Center for Veterinary Medicine also approved GTC’s New Animal Drug Application, the first of its kind to regulate genetically engineered animals. This is now required for a recombinant technology used to develop transgenic animals, such as the goats that produce recombinant antithrombin, the company reports.
“The approval of ATryn marks a significant milestone in the development of this innovative recombinant technology and delivers a new therapeutic option to benefit hereditary antithrombin deficient patients who are undergoing surgery or childbirth procedures,” said Geoffrey F. Cox, Ph.D., GTC’s chairman and CEO.