CV Therapeutics saw its share price surge by as much as 13% on the Nasdaq Stock Exchange yesterday after the US biotechnology company revealed that a clinical trial of its angina treatment, Ranexa (ranolazine), met its primary endpoint of reducing weekly angina frequency versus placebo in chronic angina patients.
The 565-patient trial, known as Erica, was conducted under a US Food and Drug Administration special protocol assessment process, following an approvable letter issued in October 2003 and the data could support the product’s approval for the treatment of chronic angina in a restricted patient population. The company expects to submit an amendment to the Ranexa filing with the FDA by the end of the third quarter of the year, with a decision on approvability expected in the first half of 2006, and also plans to present the trial results at a future scientific conference.
If approved, CV Therapeutics says that Ranexa would represent the first new class of anti-anginal therapy in the US in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. It affects approximately 6.4 million people in the US alone.