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Sanofi-Aventis' rimonabant accepted for filing by US FDA
Paris | Saturday, June 25, 2005, 08:00 Hrs  [IST]

The United States Food and Drug Administration has accepted for filing Sanofi-aventis' New Drug Application (NDA) for rimonabant, the first agent in a new therapeutic class known as selective cannabinoid type 1 (CB1) blockers.

Rimonabant, discovered and developed by sanofi-aventis, is thought to represent a new approach for the comprehensive management of cardiovascular risk factors. The compound has been studied to date in over 6,500 overweight and obese adults for up to 2 years, according to a company release.

As the first selective CB1 blocker, the effects of rimonabant on lipid and glucose metabolism, insulin resistance and reduced intra-abdominal adiposity, evidenced by a reduction in waist circumference, have been studied. Abdominal obesity is recognized as a significant risk factor in the development of cardiovascular disease.

Rimonabant also has been studied by sanofi-aventis as an aid to smoking cessation based on studies for up to one year in over 6,500 smokers motivated to quit smoking, the release says.

A Marketing Authorization Application to the European Medicines Agency (EMEA) for rimonabant has also been submitted.

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