Diet Drug Acomplia Seen Unlikely to Get FDA Approval for 'Metabolic Syndrome'
If you were hoping that diet drug rimonabant (Acomplia / Zimulti) would be approved for treatment of "metabolic syndrome" so your insurance company would be more likely to pay for your weight-loss efforts, the current thinking at the U.S. Food and Drug Administration does not appear very encouraging.
The FDA’s Metabolic and Endocrine Division has just released its long-awaited revision of its 1996 clinical guidance for development of weight-loss drugs, and it provides specific guidance for companies like Sanofi-Aventis seeking to make metabolic syndrome claims.
For the past two years, Sanofi has focused all its presentations of clinical trial data for Acomplia on "metabolic syndrome," clearly believing insurers -- notoriously reluctant to pay for diet pills -- are more likely to cover a drug used to treat the cluster of conditions that increase the risk of cardiovascular disease and type 2 diabetes.
If this is accurate, many obese and overweight individuals hoping that the FDA will finally approve Acomplia for sale in the United States this summer had better start getting used to the idea that they probably are going to be spending their own money on the diet drug.
