06.14.07
The FDA Endocrinologic and Metabolic Drugs Advisory Committee did not recommend approval of Sanofi-Aventis' rimonabant (Zimulti / Acomplia) to the FDA for use in obese and overweight patients with associated risks factors. The company will continue to work closely with the FDA regarding the committee's recommendations. The FDA will take action by July 26, 2007 for rimonabant.
Rimonabant is the first member of a new therapeutic class of drugs that selectively block the CB1 receptors of the endocannabinoid system (ECS). When working normally, this system of receptors in the brain and throughout the body helps regulate food intake and how the body uses and stores fats and sugars. Rimonabant is currently approved in 37 countries and is marketed in 18 as Acomplia.
Additional safety data from ongoing clinical studies with rimonabant show the most common adverse events were consistent across studies and included gastrointestinal (nausea, vomiting, diarrhea), nervous system (headache, dizziness, paresthesia/hypoesthesia/dysesthesia) and psychiatric disorders (anxiety, insomnia, depressed mood and depression). These adverse events generally occurred within the first two to three months, and were often mild to moderate.
Rimonabant is the first member of a new therapeutic class of drugs that selectively block the CB1 receptors of the endocannabinoid system (ECS). When working normally, this system of receptors in the brain and throughout the body helps regulate food intake and how the body uses and stores fats and sugars. Rimonabant is currently approved in 37 countries and is marketed in 18 as Acomplia.
Additional safety data from ongoing clinical studies with rimonabant show the most common adverse events were consistent across studies and included gastrointestinal (nausea, vomiting, diarrhea), nervous system (headache, dizziness, paresthesia/hypoesthesia/dysesthesia) and psychiatric disorders (anxiety, insomnia, depressed mood and depression). These adverse events generally occurred within the first two to three months, and were often mild to moderate.