The European Commission has granted marketing authorisation for Sanofi’s Multaq (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 EMEA.
Multaq 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 discovered and developed by Sanofi-aventis is an anti-arrhythmic drug approved in the EU that has shown a clinical benefit to reduce cardiovascular hospitalisations or death from any cause in patients with AF/AFL as described in the Athena trial.
Marc Cluzel, executive vice president of research and development at Sanofi-aventis, said: “The approval of Multaq in the European Union is important news for atrial fibrillation patients who will now have access to a new treatment approach.
“The approval of Multaq 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 Multaq is not recommended in these patients.
The marketing authorisation of Multaq was based on the review of a comprehensive clinical data package including seven international, multi-center, randomised clinical trials involving more than 7000 patients with almost 4000 patients receiving dronedarone during the clinical development program.