Sanofi-Aventis has received US Food and Drug Administration (FDA) approval for Multaq (dronedarone) 400mg tablets for the treatment of patients with atrial fibrillation (AF) or atrial flutter (AFL).
The FDA approval is based on five international, multi-centre, randomised clinical trials involving nearly 6,300 patients.
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The Athena trial evaluated the efficacy and safety of Multaq in patients with AF/AFL or a recent history of these conditions. The results showed that 71% of these patients had no heart failure and 29% were in NYHA class IIII with stable heart failure.
The trial also showed that Multaq 400mg BID, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalisation or death from any cause by 24% when compared to placebo. This meets the study’s primary endpoint.
ATHENA study co-principal investigator and professor of medicine and director, Division of Cardiology Stuart Connolly said that the availability of the new treatment was exciting news.
“Based on clinical studies, Multaq reduces the risk of cardiovascular hospitalisations in patients with AF/AFL, this outcome could change the way we approach the management of the disease,” Connolly said.
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