October 7, 2008
Ovation Pharmaceuticals’s ATryn BLA Accepted for Review By FDA
Ovation Pharmaceuticals, a biopharmaceutical company, has announced that the FDA has accepted for review the biologics license application for ATryn.
Ovation acquired the exclusive US license to ATryn from GTC Biotherapeutics, allowing the company to develop and commercialize the product in the US. The acceptance of the biologics license application (BLA) comes just one month after the FDA assigned a priority review to the product, which has also been granted orphan drug designation. An action letter is expected in February 2009.
ATryn is under review for the treatment of a rare disorder called hereditary antithrombin deficiency, involving people who do not have sufficient antithrombin in their bloodstream.
Jeffrey Aronin, Ovation's president and CEO, said: "We are excited about how well ATryn is progressing through the regulatory process and are particularly pleased that the FDA has accepted the filing for review. This is a key milestone that paves the way for the FDA to consider its approval early in 2009 following the Blood Products Advisory Committee meeting in January 2009."