FDA to review potential anti-arrhythmic claims for Ranexa

Dec 10 2007

CV Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it will evaluate the approval of potential anti-arrhythmic claims for Ranexa (ranolazine extended-release tablets) as part of its ongoing review of the Company's supplemental new drug application (sNDA).

This follows the FDA's acceptance of an sNDA seeking expansion to the approved product labeling for Ranexa to include a first line angina indication and a significant reduction in cautionary language as well as a separate NDA for a potential labeling change to add reduction of hemoglobin A1c (HbA1c) in coronary artery disease patients with diabetes. The two sNDAs are being reviewed by the FDA Division of Cardiovascular and Renal Products and the NDA is being reviewed by the FDA Division of Metabolism and Endocrinology Products.

The Prescription Drug User Fee Act (PDUFA) action date for the sNDAs and the NDA is July 27, 2008. The FDA has requested, and CV Therapeutics has paid three separate user fees to support the review of both sNDAs and the NDA.

"We anticipate receiving approval for first line angina use, which would significantly expand the patient population eligible to receive Ranexa, and we are very pleased that the FDA also is now evaluating separate potential anti- arrhythmic and HbA1c reduction claims for Ranexa on the same timeline," said Louis G. Lange, CV Therapeutics chairman and chief executive officer.

In September 2007, data published in Circulation and presented at the European Society of Cardiology Congress 2007 in Vienna, Austria showed that Ranexa reduced ventricular arrhythmias in patients receiving Ranexa compared to placebo in the MERLIN TIMI-36 study.

Patients receiving Ranexa had a 37 percent reduction in their relative risk of ventricular tachycardia lasting eight beats or more (p<0.001) and there were fewer episodes of sudden cardiac death observed in patients taking ranolazine (56) than in patients taking placebo (65).

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.

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.

http://www.cvt.com/