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FDA sets conditions for rimonabant approval
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Sanofi-Aventis has announced that the FDA has issued an approvable letter for rimonabant as a weight loss treatment but that certain conditions must be met before final approval is given. The FDA also issued a nonapprovable letter for rimonabant as a treatment for smoking cessation.
Neither the company nor the FDA had released information as Cardiology Today went to press about the conditions that must be met before the drug could be approved or how long the process could take to meet those conditions. The pharmaceutical company said it would continue to “work in close collaboration with the FDA.”
This news coincided with the release of the RIO-North America trial results in the Journal of the American Medical Association. The trial reported a 4.5% weight loss with the 20 mg daily dose, as well as favorable changes in blood lipid levels compared to placebo.
In the same issue, physicians at the NHLBI noted in an editorial the study’s “failure to obtain final weight measurements on about half of the randomized participants” and said the study’s conclusions can be questioned due to the high attrition rates.