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.