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news.Sanofi-Aventis' weight loss drug Zimulti has failed to win recommendation by the FDA Endocrinologic and Metabolic Drugs Advisory Committee because of concerns that it may increase suicidal thoughts and depression.
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Rimonabant, the active ingredient of the drug, is currently approved in 37 countries and is marketed in 18. In those countries where it is currently sold, the product is marketed as Acomplia. The committee’s influence, however, means the drug is unlikely to be ever launched in the US.
Sanofi-Aventis said it will continue to work closely with the FDA to address the committee’s recommendations. The FDA has set a PDUFA action date of July 26, 2007 for rimonabant.
Known generically as rimonabant, Zimulti helps people lose weight by blocking receptors in the brain linked to hunger signals. When working normally, this system of ‘CB1’ receptors in the brain and throughout the body (liver, muscle, abdominal adipose tissue, gastro-intestinal tract and pancreas), among other functions, helps regulate food intake and how the body uses and stores fats and sugars.