FDA TO REVIEW SANOFI-AVENTIS' ACOMPLIA APPLICATION

Sanofi-aventis has announced that the FDA has accepted the company's complete response to the February approvable letter for its new drug application (NDA) for Acomplia (rimonabant). The FDA's action date for the application is April 26, 2007.

Rimonabant is a first-in-class cannabinoid type 1 receptor blocker. Last week the company presented study results showing that patients with Type 2 diabetes not currently treated with antidiabetic medications experienced significant improvements in blood sugar control and weight as well as other risk factors such as HDL cholesterol and triglycerides when compared with placebo.

In Europe, the drug was approved in June as an adjunct to diet and exercise for promoting weight loss in obese or overweight patients with associated risk factors, such as Type 2 diabetes or dyslipidaemia.

In the U.S., sanofi-aventis originally submitted an application for the drug as a weight-loss and smoking-cessation treatment. While the FDA issued an approvable letter for the weight indication, it issued a not approvable letter for smoking cessation.