FDA extends review of Sanofi-Aventis' anti-obesity drug Acomplia until late July

French drugmaker Sanofi-Aventis says that the US Food and Drug Administration has decided to extend its review of the anti-obesity drug Acomplia (rimonabant) by three months, with a final decision now expected no earlier than July 27.

Acomplia is a first-in-class cannabinoid receptor antagonist, which lowers the over-activity of the endocannabinoid system that is thought to play a role in regulating body weight and metabolism. The drug is currently approved as an adjunct to diet and exercise for the treatment of obesity in the UK, Germany, Denmark, Sweden, Finland, Norway, Ireland, Austria and Argentina.

Following the news of the review extension, Sanofi said said that it has completed the submission of data from the SERENADE (Study Evaluating Rimonabant Efficacy in Drug-Naive DiabEtic patients) program as an addition to the New Drug Application under FDA consideration.