Ranexa(R) Significantly Reduces Incidence of CV Death, MI or Recurrent Ischemia in MERLIN TIMI-36 Patients With Elevated BNP
2007 NOV 19 -- CV Therapeutics, Inc. (NASDAQ:CVTX) announced that Ranexa(R) (ranolazine extended-release tablets) reduced the relative risk of the primary composite endpoint of CV death, myocardial infarction or recurrent ischemia by 21 percent compared to placebo in 1,935 patients with an elevated (>80pg/ml) level of b-type natriuretic peptide (BNP) in the MERLIN TIMI-36 study (p=3D0.009). The data were presented today by Dr. David Morrow of the TIMI Study Group at the American Heart Association Scientific Sessions in Orlando, Florida. Ranolazine is believed to exert its anti-ischemic effects through ion channel activity which may ultimately reduce left ventricular (LV) wall stress and improve diastolic dysfunction. BNP rises in response to LV wall stress and is a potent indicator of risk in acute coronary syndromes (ACS). "The potential enhanced efficacy of ranolazine in patients with elevated BNP in this analysis is consistent with the drug's mechanism of action. Elevated BNP is among the most powerful indicators of risk for ACS patients, and it is very intriguing to see the potentially beneficial effects of ranolazine in this group of MERLIN TIMI-36 patients," Morrow said. "Few interventions have been shown to modify the risk associated with increased BNP. This finding warrants prospective confirmation," he added. In accordance with a special protocol assessment agreement between the U.S. Food and Drug Administration (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. In September 2007, the Company submitted a supplemental new drug application to the FDA seeking a new indication for first line angina and a significant reduction in cautionary language. 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. Keywords: Acute Coronary Syndrome, Biotechnology Business, Biotechnology Company, CV Therapeutics, Cardiology, Coronary Artery Disease, Coronary Disease, Drug Development, Enzyme Inhibitor, Heart Attack, Heart Disease, Ischemia, Myocardial Infarction, Ranolazine, Therapy, Treatment, CV Therapeutics Inc. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2007, Biotech Business Week via NewsRx.com.
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