The priority review is granted to applications in which a new indication or new drug product, if approved, has the potential to present a safe and effective therapy where no satisfactory alternative exists compared to currently available therapies or marketed products.
A registration dossier is also under regulatory review by the European Medicines Agency for a marketing authorization application.
Marc Cluzel, senior vice president of R&D for Sanofi-Aventis, said: “We are pleased that the FDA has designated Multaq for priority review. This follows the exciting results of the Athena study that showed Multaq significantly decreased the risk of cardiovascular hospitalizations or death from any cause in patients with atrial fibrillation.”