Sanofi-aventis’ Multaq has become the first new anti-arrhythmic drug to be approved in the European Union in the last 10 years.
The European Commission has granted marketing authorisation for Multaq (dronedarone – 400mg Tablets) in all 27 European member states. The approval follows the CHMP’s positive opinion issued on September 25, 2009.
The drug 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.
It is the first 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.
“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,” said Marc Cluzel, Executive Vice President, Research and Development, sanofi-aventis. “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 marketing authorisation was based on a clinical data package that included seven international clinical trials involving more than 7000 patients, with almost 4000 patients receiving dronedarone during the 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 hospitalisations for arrhythmia in the European Union,” said Dr Stefan H. Hohnloser, Goethe University’s Division of Clinical Electrophysiology, Frankfurt, Germany.
He added: “Multaq 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.”
The first launches of Multaq are expected to take place in the United Kingdom and Germany in January 2010.