ATryn(R) (antithrombin alfa) BLA Filing Accepted by FDA.DEERFIELD, Ill. -- OVATION Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has accepted for review the Biologics License Application (BLA BLA abbr. Bachelor of Liberal Arts ) for ATryn([R])(antithrombin alfa). OVATION acquired the exclusive U.S. license to ATryn in August from GTC GTC See: Good 'til cancelled order GTC See good-till-canceled order (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 orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the 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 clotting /clot·ting/ (klot´ing) coagulation (1). clotting the formation of a jellylike substance over the ends or within the walls of a blood vessel, with resultant stoppage of the blood flow. 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 dizziness: see vertigo. , headache, bleeding, nausea, bleeding at injection site and increased bleeding during treatment. About OVATION Pharmaceuticals OVATION is a fast-growing biopharmaceutical company that develops, manufactures and markets medically necessary medically necessary Managed care adjective Referring to a covered service or treatment that is absolutely necessary to protect and enhance the health status of a Pt, and could adversely affect the Pt's condition if omitted, in accordance with accepted therapies to satisfy unmet medical needs for patients with severe illnesses. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients' lives through its focus on central nervous system, hematology/oncology, and hospital-based therapies. The four new launches the company expects over the next three years will be fueled by its late-stage CNS See Continuous net settlement. CNS See continuous net settlement (CNS). pipeline, which is one of the most robust in the industry. OVATION has been recognized for excellence in the global pharmaceutical and biotechnology industries with the 2006 and 2007 "Pharma Company of the Year" award from Scrip magazine for small to mid-sized enterprises. More information about the company, its products and full prescribing information may be found at www.ovationpharma.com. |
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