Sanofi-aventis has received FDA approval for Multaq (dronedarone) 400mg tablets for patients with atrial fibrillation (AF) or atrial flutter (AFL). The FDA approval is based on five international, multi-center, randomized clinical trials involving nearly 6,300 patients.
Athena trial evaluated the efficacy and safety of Multaq in patients with AF/AFL or a recent history of these conditions (71% of these patients had no heart failure, 29% were in NYHA class IIII with stable heart failure). The trial showed that Multaq 400mg BID, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24% when compared to placebo. This meets the study’s primary endpoint.
Stuart Connolly, Professor of Medicine & Director, Division of Cardiology, and Co-Principal Investigator in the ATHENA study, said: “It is exciting that Multaq will now be available as a treatment option for patients with paroxysmal or persistent atrial fibrillation or atrial flutter.”
“Based on clinical studies, Multaq reduces the risk of cardiovascular hospitalizations in patients with atrial fibrillation / atrial flutter, this outcome could change the way we approach themanagement of the disease,” he added.