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news.Sanofi-Aventis has reported that the Cardiovascular and Renal Drugs Advisory Committee voted 10 to three in favor of the approval of Multaq by the FDA to treat patients with non-permanent atrial fibrillation.
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As demonstrated in the Athena trial, Multaq is the only anti-arrhythmic drug to have shown in a clinical study a significant reduction in morbidity and mortality in patients with atrial fibrillation/atrial flutter or a recent history of these conditions, said Sanofi-Aventis.
The FDA is not bound by the committee’s recommendation, but it takes its advice into consideration when reviewing new drug applications.
Jean-Pierre Lehner, chief medical officer of Sanofi-Aventis, said: “Sanofi-Aventis is pleased with the outcome of today’s discussions and positive recommendation. The panel’s insightful feedback which concluded with a positive vote, is an important step in gaining FDA approval of Multaq.”