SANOFI-AVENTIS' ACOMPLIA APPROVED IN MEXICO

Sanofi-aventis announced that Acomplia (rimonabant), the first drug in a new class that targets multiple cardiometabolic risk factors, has received marketing authorization from Mexican health authorities.

Mexico's Ministry of Health has granted the registration for Acomplia (rimonabant) in the following two indications: as adjuvant to diet and exercise and/or any therapeutic scheme in obese or overweight patients with associated risk factors such as Type 2 diabetes or dyslipidemia; and as adjuvant treatment to diet and exercise to improve the glycemic control in Type 2 diabetes patients who are overweight in combination with conventional treatment such as metformin or sulfonylurea.

The approval is based on comprehensive efficacy and safety data, including data from the RIO clinical trial program, which involved more than 6,600 patients worldwide, of which more than 4,500 were studied for up to two years. Results from the RIO trial demonstrated that one Acomplia 20-mg tablet taken every day significantly decreased weight, waist circumference, HbA1c and triglycerides and increased HDL cholesterol levels. The RIO-Diabetes study recently published in The Lancet showed that rimonabant significantly improved weight, blood sugar levels and other cardiometabolic risk factors in people with Type 2 diabetes.