The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the US Food and Drug Administration (FDA) discussed a range of issues relating to the review of Ranexa for the treatment of chronic angina, but did not vote on any matters presented to it.
"We appreciate the thorough review by the advisory committee of Ranexa and we look forward to meeting with the FDA as soon as possible to discuss next steps," said Louis G Lange, MD, PhD, chairman and chief executive officer of CV Therapeutics.
The FDA or other foreign regulatory agencies have approved none of CV Therapeutics’ products, including Ranexa, for marketing. On October 30, the FDA sent CV Therapeutics, Inc. an approvable letter indicating that there is evidence that Ranexa is an effective anti-anginal, and that additional clinical information is needed prior to approval. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States. CV Therapeutics' products have not been determined to be safe or effective in humans for any uses.
If approved, Ranexa would represent the first new class of therapy for angina introduced in the United States in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease (CAD) and marked by repeated and sometimes unpredictable attacks of chest pain. It affects 6.6 million people in the US, according to the American Heart Association, and results in more than 700 million angina attacks per year in the US
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases.