Sanofi-aventis: Multaq(R) Approved in the European Union for Patients With Atrial Fibrillation

First New Anti-Arrhythmic Drug to be Approved in the European Union in the Last 10 Years

02-Dec-2009 - France

Sanofi-aventis announced 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 onSeptember 25, 2009by 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," saidMarc 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) <35%, the use of MULTAQ is not recommended in these patients.

The marketing authorisation of Multaq(R) 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.

https://www.bionity.com/en/news/110268/sanofi-aventis-multaq-r-approved-in-the-european-union-for-patients-with-atrial-fibrillation.html