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news.CV Therapeutics' Ranexa has met the primary endpoint of reducing weekly angina frequency compared to placebo in chronic angina patients, in an approval-enabling study.
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Ranexa (ranolazine) was well tolerated in the study, named ERICA, and there were no cases of syncope (fainting). Under the trial’s special protocol assessment (SPA) process agreement, these positive data could support the approval of Ranexa for the treatment of chronic angina in a restricted patient population.
CV Therapeutics expects to prepare the final study report, integrate the data from ERICA into the safety and efficacy database of Ranexa trials and submit an amendment to the Ranexa new drug application (NDA) to the FDA by the end of the third quarter of 2005. Once the company submits the NDA amendment, a six month FDA review could enable the potential approval and subsequent launch of Ranexa in a restricted patient population in the first half of 2006.
If approved, Ranexa would represent the first new class of anti-anginal therapy in the US in more than 25 years.