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.