The FDA has also granted GTC permission to submit the associated biologics license application, or BLA, for ATryn on a rolling basis. Fast Track status speeds up the review process allowing products which address an unmet medical onto the market quickly.
The BLA requesting marketing approval for ATryn will be submitted as sections are completed rather than waiting for all sections to be submitted together, enabling the FDA review to begin sooner. GTC anticipates filing the initial sections with the FDA in the fourth quarter and completing the rolling submission after all clinical data is gathered, analyzed, and available for the BLA, which is planned to be by the end of the first quarter of 2008.
ATryn is GTC’s recombinant form of human antithrombin, a protein with anticoagulant and anti-inflammatory properties that is normally present in human plasma. ATryn is being investigated in a Phase III comparative study for the treatment of hereditary antithrombin deficiency (HD), patients at risk for developing deep vein thrombosis or thromboembolism while undergoing surgical procedures or childbirth. Top line data from this study is planned to be available late in the fourth quarter.
ATryn is produced in the milk of goats that have incorporated the human antithrombin gene such that it is only expressed during lactation. This technology enables an alternative supply of antithrombin that is unconstrained by the limited availability of plasma-sourced material.