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Sanofi Pulls Application for Obesity Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Sanofi-Aventis is withdrawing its application for rimonabant for the treatment of obesity in the U.S. A U.S. advisory panel recently said that the drug should not be approved because it may increase suicidal thoughts and depression.

The company said it is working to resubmit the drug, known as Acomplia and Zimulti, at a future date and would undertake necessary discussions with the FDA on required modifications to its file. SA may still file for approval based on the success of a large trial currently underway regarding its safety and efficacy. In the EU, regulators are still reviewing the latest safety data on the drug and a final decision is expected next month.

Acomplia is currently approved in 42 countries and marketed in 20 to treat obesity and overweight patients with associated cardiovascular risk factors.

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