April 25, 2007 — CV Therapeutics Inc. has announced that data from the MERLIN TIMI-36 study will be published in this week's issue of The Journal of the American Medical Association (JAMA). The company plans to ask the FDA to modify the existing product labeling for Ranexa (ranolazine extended-release tablets) by reducing cautionary language and expanding the indication to include first-line angina.
The data and results published in JAMA from the MERLIN TIMI-36 study showed that patients with acute coronary syndromes (ACS) receiving Ranexa had no adverse trend in death or arrhythmias and had statistically significant reductions of clinically significant arrhythmias (p
Analysis of secondary efficacy endpoints showed that Ranexa reduced worsening angina by 23 percent (p=0.023) compared to placebo, and reduced the need to increase antianginal medication by 19 percent (p=0.003) compared to placebo.
In accordance with a special protocol assessment agreement between the 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, and plans to submit a supplemental new drug application (sNDA) to the FDA in fall 2007.
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.
An editorial authored by Kristin Newby, M.D. and Eric Peterson, M.D. from Duke University Medical Center accompanies the MERLIN TIMI-36 publication in JAMA.
For more information visit www.cvt.com.