PARIS The Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee voted 10-to-3 in favor of a drug by Sanofi-Aventis.
Sanofi announced Thursday that the committee favored approval of Multaq (dronedarone), a drug for treating patients with non-permanent atrial fibrillation, also known as AF, which affects around 2.5 million Americans and is the leading cause of hospitalizations for arrythmia in the United States.
The committee’s recommendations may influence the FDA’s decision whether to approve a drug, but they do not require the agency to give approval.
“Sanofi-Aventis is pleased with the outcome of today’s discussions and positive recommendation,” Sanofi chief medical officer Jean-Pierre Lehner said in a statement. “The panel’s insightful feedback which concluded with a positive vote is an important step in gaining FDA approval of Multaq.”