Sanofi-Aventis atrial fibrillation drug ‘under review’ by EMEA

Sanofi-Aventis has reported that Multaq (dronedarone), its treatment candidate for patients with atrial fibrillation, currently has its registration dossier under regulatory review by the European Medicines Agency (EMEA).

Multaq is a multi-channel blocker with anti-adrenergic properties that affects calcium, potassium and sodium channels.

As well as the review in Europe for a marketing authorisation application, the compound has also been assigned priority review status by the US Food and Drug Administration.

This review period began at the end of July 2008 and such reviews are granted to drugs which have the potential to offer a safe and effective treatment option in an area of currently unmet clinical need.

Marc Luzel, senior vice-president of research and development for Sanofi-Aventis, said the company is pleased Multaq has been granted priority review status.

“This follows the exciting results of the landmark Athena study that showed Multaq significantly decreased the combined risk of cardiovascular hospitalisations and death from any cause in patients with atrial fibrillation,” he added.

In May 2008, Sanofi-Aventis said Multaq has the potential to reduce death and hospitalisation in patients experiencing an atrial flutter and “change the face” of the management of the condition.