FDA to evaluate CV Theraputics' Ranexa claims

PALO ALTO, Calif. The Food and Drug Administration has notified CV Therapeutics that it will evaluate the approval of potential anti-arrhythmic claims for Ranexa, according to Reuters. Ranexa is approved for the treatment of chronic angina in patients who already are using amlodipine, beta-blockers or nitrates.

This follows the FDA’s acceptance of two supplemental and one new drug application for Ranexa. The two supplemental applications state that Ranexa’s labeling should include a first-line angina indication and a significant reduction in cautionary language. The new drug application calls for a labeling change to add reduction of hemoglobin A1c in coronary artery disease patients with diabetes.

“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 Lange, CV Therapeutics' chairman and chief executive officer.