ATryn - RECOMBINANT HUMAN ANTITHROMBIN
GTC's lead product, ATryn, a recombinant form of human antithrombin, also known as ATIII, is at the forefront of transgenic technology for the production of biotherapeutics. Antithrombin is a plasma protein with anticoagulant and anti-inflammatory properties that, like many other therapeutic proteins which are currently derived from the human blood supply, has been difficult to express using conventional recombinant protein production methods.
FULL PRESCRIBING INFORMATION - US
FULL PRESCRIBING INFORMATION - EU
In the United States the Food and Drug Administration (FDA) approved ATryn for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient, or HD, patients. ATryn is the first ever transgenically produced therapeutic protein and the first recombinant antithrombin approved in the U.S. Atryn is now available for sale in the United States.
In August of 2006, following a positive opinion by the CHMP, the European Commission approved ATryn under exceptional circumstances for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency.