The final portion of the biologics license application (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.
GTC has requested priority review. Assuming that priority review is granted, GTC anticipates the FDA reaching a decision on the BLA filing in the first quarter of 2009. A definitive agreement has been signed with Ovation Pharmaceuticals for commercialization and development rights in the US.
ATryn has been approved for use in a similar indication in the EU. Leo Pharma is marketing ATryn in Europe and is conducting further clinical development.