CV Therapeutics Inc has submitted a new drug application (NDA) for Ranexa (ranolazine) to the U.S. Food and Drug Administration (FDA) seeking approval of Ranexa for the treatment of chronic angina. If approved, Ranexa, which partially inhibits fatty acid oxidation (pFOX), would represent the first in a new class of anti-anginal therapy in more than 20 years.
"This NDA submission is important because Ranexa could offer a potential new approach to the treatment of chronic angina. We believe that Ranexa could address the need for new treatment options for angina," said Louis G. Lange, chairman and chief executive officer of CV Therapeutics.
The NDA consists of more than 300,000 pages in over 1,100 volumes, and contains data from more than 3,300 angina patients and healthy volunteers, including over 25,000 electrocardiograms.
Chronic angina is a serious and potentially debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. The condition can significantly compromise patients' lives, causing many patients to curtail activities to avoid an attack.
Chronic angina is a growing health problem, affecting millions of people, generally over the age of 55. Annually, it costs the nation tens of billions of dollars in healthcare services and lost work. Approximately 6.4 million people in the U.S. live with chronic angina, with an additional 400,000 people newly diagnosed each year. The U.S. Census Bureau projects that the 55-plus age group -- the group most at-risk for angina -- will increase by 80 per cent over the next 30 years.
CV Therapeutics is a development-stage company. None of its products have been approved for marketing by the United States Food and Drug Administration (FDA) or other foreign regulatory agencies. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug (IND), 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.