The European Commission has granted marketing authorisation for Sanofi-Aventis‘s Multaq (dronedarone), making it the first new anti-arrhythmic drug to be approved in the EU in the last ten years.
The approval, which will make the drug available in all 27 European member states, follows an EC positive opinion issued in September by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Multaq is indicated for clinically stable adult patients with a history of or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.
Sanofi-Aventis MD and executive vice-president of research and development Marc Cluzel said that this approval would provide patients with a new treatment approach.
“The approval of Multaq is the result of more than 15 years of research and development,” Cluzel said.
Marketing authorisation was based on comprehensive clinical data including seven international, multi-centre, randomised clinical trials involving more than 7,000 patients, with almost 4,000 patients receiving dronedarone during the clinical development programme.