PARIS--30 Nov--PRNewswire-AsiaNet/InfoQuest
- First New Anti-Arrhythmic Drug to be Approved in the European Union in the Last 10 Years
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the European Commission has granted marketing authorization for Multaq(R) (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).
Multaq(R) 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.
Multaq(R) 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 Multaq(R) 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 Multaq(R) 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)