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SANOFI-AVENTIS UPDATES STATUS OF ACOMPLIA APPLICATION

February 13, 2007

Sanofi-aventis announced that the FDA review period for its application for Acomplia has been extended by three months and will now end July 27.

In December 2006 the company announced that the FDA accepted its complete response to the February 2006 approvable letter for the Acomplia (rimonabant) application and set an action date for April 26.

Sanofi-aventis also announced the submission of the SERENADE clinical study report to the FDA.

SERENADE was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing rimonabant 20 mg once daily with placebo in improving blood sugar control in treatment-naïve Type 2 diabetes patients not adequately controlled by diet alone for a period of six months.

The study demonstrated that patients with Type 2 diabetes experienced significant improvements in blood sugar control and weight as well as other risk factors such as HDL cholesterol and triglycerides with Acomplia compared with placebo.