Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the European Commission has granted marketing authorization for dronedarone – 400mg Tablets in all 27 European member states. This approval follows the European Commission positive opinion issued on September 25, 2009 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine agency (EMEA).
Dronedarone is indicated in adult clinically stable patients with a history of, or current non permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.
Dronedarone discovered and developed by sanofi-aventis is the first anti-arrhythmic drug approved in the European Union that has shown a clinical benefit to reduce cardiovascular hospitalizations or death from any cause in patients with AF/AFL as described in the ATHENA trial. “The approval of dronedarone in the European Union is important news for atrial fibrillation patients who will now have access to a new treatment approach,” said Marc Cluzel, MD, Executive Vice President, Research and Development, sanofi-aventis. “The approval of dronedarone is the result of more than 15 years of research and development conducted by sanofi-aventis and supported by the commitment of the experts involved in the clinical development program and AF patients participating in the trials.”
The use of dronedarone in unstable patients with NYHA class III and IV heart failure is contraindicated. Because of limited experience in stable patients with recent (1 to 3 months) NYHA class III heart failure or with Left Ventricular Ejection Fraction (LVEF) <35%, the use of dronedarone is not recommended in these patients.
The marketing authorisation of dronedarone was based on the review of a comprehensive clinical data package including seven international, multi-center, randomized clinical trials involving more than 7000 patients with almost 4000 patients receiving dronedarone during the clinical development program.
“This European approval is good news for doctors and patients since atrial fibrillation affects about 4.5 million people in Europe and represents one-third of hospitalizations for arrhythmia in the European Union” said Dr. Stefan H. Hohnloser J.W., Goethe University’s Division of Clinical Electrophysiology, Frankfurt, Germany, principal investigator of the ATHENA study. “dronedarone is a significant step forward which could change the way we approach the management of atrial fibrillation and offers a new treatment option to physicians in a field where there has been no significant anti-arrhythmic drug innovation for almost 20 years.”