FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) has completed its submission of the final portion of the Biologics License Application, or BLA, for ATryn® in the United States. The final portion of the BLA submission includes all of the clinical safety and efficacy data generated from studies of ATryn®, including the pivotal study supporting product licensure. ATryn® is GTC’s recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The BLA requests market authorization for the use of ATryn® in the prophylactic treatment of deep vein thrombosis and other thromboembolisms in patients with hereditary antithrombin deficiency who are undergoing high risk surgical and childbirth procedures. There are no other recombinant forms of antithrombin available to treat this patient population.
