Biopharmaceutical company, CV Therapeutics, Inc. announced that the US Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) as well as its new drug application (NDA) for chronic angina drug Ranexa.
The Prescription Drug User Fee Act (PDUFA) action date for both applications is July 27, 2008.The sNDA seeks an expansion to the approved product labelling for Ranexa (ranolazine extended-release tablets) to include a first line angina indication and a significant reduction in cautionary language. The sNDA is being reviewed by the FDA Division of Cardiovascular Renal Products.
After receiving this sNDA submission from CV Therapeutics, the FDA initiated, and has now accepted for filing, a separate NDA on behalf of the Company to provide a clinical review of a potential labelling change to add reduction of haemoglobin A1c (HbA1c) in coronary artery disease patients with diabetes. This NDA is being reviewed by the FDA Division of Metabolism and Endocrinology Products.
"With the Ranexa sNDA and NDA now accepted for filing, the NDA under review for regadenoson and our marketing authorization application for ranolazine under review in Europe, we are very excited to have several major applications in process and are looking forward to multiple potential approvals in 2008," said Louis G. Lange, chairman and chief executive officer, CV Therapeutics.
In accordance with a special protocol assessment agreement between the FDA and CV Therapeutics, the company believes that data from the MERLIN TIMI-36 study could support expansion of the existing Ranexa indication to first line angina.
Ranexa is currently indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates.
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialisation of novel, small molecule drugs for the treatment of cardiovascular diseases.