FDA to process review of Sanofi obesity drug

The FDA accepted the filing the Sanofi’s new drug application 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 two years.

Despite therapeutic advances in recent decades, cardiovascular disease remains the leading cause of mortality worldwide. Current treatments generally target risk factors individually, rather than providing a comprehensive management approach to such cardiovascular risks as dyslipidemia, abdominal obesity and insulin resistance, which comprise the metabolic syndrome.

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 has also 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.

An application to market the drug in Europe has also been submitted.