sanofi-aventis announced that the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee did not recommend approval of rimonabant (Zimulti) to the US FDA for use in obese and overweight patients with associated risks factors.
sanofi-aventis will continue to work closely with the FDA to address the committee's recommendations. The FDA has set a PDUFA action date of July 26, 2007 for rimonabant, a sanofi-aventis press release said.
Rimonabant is currently approved in 37 countries and is marketed in 18. In those countries where it is currently sold, the product is marketed as Acomplia.
Rimonabant is the first and the most studied member of a new therapeutic class of drugs that selectively block the CB1 receptors of the endocannabinoid system (ECS), and the drug's development has deepened scientists' understanding of the ECS. When working normally, this system of receptors in the brain and throughout the body (liver, muscle, abdominal adipose tissue, gastro-intestinal tract and pancreas), among other functions, helps regulate food intake and how the body uses and stores fats and sugars.
Rimonabant, and its effects on the ECS, have been extensively studied, resulting in well-defined efficacy and safety profiles. The Committee reviewed findings from a comprehensive clinical trials programme that included data from 59 completed clinical studies enrolling more than 15,000 patients.
Additional safety data were presented from ongoing clinical studies and more than 110,000 individuals in Europe and other countries who have taken rimonabant. The most common adverse events associated with rimonabant 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 2-3 months, and were often mild to moderate in intensity.