An FDA advisory panel today unanimously rejected approval of Sanofi-Aventis’ weight-loss drug rimonabant after hearing testimony that the drug increases the risk of suicidal behavior.
The panel’s finding makes it unlikely that the FDA will grant approval for the drug. The agency usually follows the advice of its advisory panels, although it is not required to do so.
The FDA is scheduled to make a final decision on rimonabant by July 27.
The company proposes selling the drug under the brand name Zimulti. Rimonabant is already sold in Europe as Acomplia.
