FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. (“GTC”, Nasdaq: GTCB) announced today that it has completed recruitment into the historical arm of the comparative clinical study of ATryn® in the treatment of patients with hereditary antithrombin deficiency, or HD, undergoing high-risk surgical or childbirth procedures. This study is expected to support a Biologics License Application, or BLA, submission with the United States Food and Drug Administration, or FDA. Evaluable records for 37 patients were obtained, meeting the required minimum of 35 HD patients. The data from the historical records were gathered under a prospective clinical protocol observing patients who had been treated with plasma-derived antithrombin products.
