Sanofi-aventis announced that the US Food and Drug Administration (FDA) has informed the company that they intend to discuss the dronedarone application at the Cardio-Renal Advisory Committee on March 18, 2009. Dronedarone was granted by the FDA a priority review status on July 31, 2008.
Dronedarone (Multaq) is an investigational treatment and the only Anti-Arrhythmic Drug (AAD) to have shown a significant reduction in morbidity and mortality in AF/AFL patients with a favourable safety profile as evidenced by a low incidence of pro-arrhythmia (including torsades de pointes) and extra-cardiac organ toxicity.