Ovation Pharmaceuticals, Inc announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ATryn (antithrombin alfa). Ovation acquired the exclusive US license to ATryn in August from GTC Biotherapeutics, allowing the company to develop and commercialize the product in this country. The acceptance of the 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, or HD, involving people who do not have sufficient antithrombin in their bloodstream. Antithrombin is a protein that helps keep blood from clotting and has anti-inflammatory properties.
"We are excited about how well ATryn is progressing through the regulatory process and are particularly pleased that FDA has accepted the filing for review," said Jeffrey S Aronin, Ovation president and chief executive officer. "This is a key milestone that paves the way for FDA to consider its approval early next year following the Blood Products Advisory Committee meeting in January."
ATryn is one of two product licensing agreements Ovation has completed in the last 60 days. With one of these products launching by the end of this year, and two more products - including ATryn - now under FDA review, the company is positioned to bring three new, orphan-designated products to market over the next year.
The most common adverse events listed in the approved European labeling that may occur during treatment with ATryn include dizziness, headache, bleeding, nausea, bleeding at injection site and increased bleeding during treatment.
Ovation is a fast-growing biopharmaceutical company that develops, manufactures and markets medically necessary therapies to satisfy unmet medical needs for patients with severe illnesses.