FDA accepts ATryn biologics license application

Oct 6 2008

The US Food and Drug Administration, or FDA, has accepted for review GTC Biotherapeutics, Inc.'s Biologics License Application, or BLA, for ATryn.

FDA's Blood Products Advisory Committee intends to review the BLA for ATryn during a meeting that is being planned for January 2009. Based on the achievement of these milestones, GTC has received $2 million in additional milestone payments from OVATION Pharmaceuticals, Inc.

As previously announced, ATryn has been designated an Orphan Drug and FDA has determined that the product fulfills the criteria for Fast Track status. The ATryn BLA will also receive Priority Review. Priority Review is granted to only to those products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Under Priority Review, the target date for FDA action on the BLA is February 7, 2009. This action date was affirmed by the FDA following preliminary review of the BLA performed in accepting the BLA.

ATryn is GTC's recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The company seeks regulatory approval of ATryn in the United States for 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 rare patient population. GTC has licensed ATryn to OVATION Pharmaceuticals, Inc. to develop and market it in the United States.