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Acomplia ™(Rimonabant) Receives 1st Marketing Authorization in North America

Posted: Thursday, November 16, 2006

Acomplia™ (rimonabant) approved in Mexico to treat obese/overweight patients with associated type 2 diabetes or dyslipidemia or to help them improve glycemic control on background of conventional antidiabetic treatment.

The Ministry of Health, has granted the registration for Acomplia™ (rimonabant) in the following therapeutic indications:
- as adjuvant to diet and exercise and/or any therapeutic scheme in obese (BMI > 30 kg/m2) or in overweight (BMI > 27 kg/m2) patients with associated risk factors such as type 2 diabetes or dyslipidemia.
- as adjuvant treatment to diet and exercise to improve the glycemic control in type 2 diabetes patients with overweight (BMI > 27 kg/m2) in combination with conventional treatment such as metformin or sulfonylurea.

Cardiometabolic risk is formed by a cluster of factors that can lead people to develop cardiovascular disease and/or type 2 diabetes. Main risk factors are abdominal obesity, high triglycerides (bad cholesterol), low HDL cholesterol level (good cholesterol), insulin resistance, elevated glucose and high blood pressure.

Cardiovascular disease and type 2 diabetes are Mexico's first and second causes of death. They are both directly related to cardiometabolic risk complications. The approval of Acomplia™ a first in class product discovered and developed by sanofi-aventis was based on comprehensive efficacy and safety data, including data from the RIO (Rimonabant in Obesity) clinical trial programme which involved more than 6,600 patients worldwide, of which over 4,500 were studied for up to two years.

About the RIO programme Results from the RIO programme demonstrated that one Acomplia™ 20 mg tablet taken every day significantly decreased weight and waist circumference, HbA1c, and triglycerides and increased HDL-cholesterol levels - the 'good cholesterol.

The RIO-Diabetes study results recently published in the Lancet shown that rimonabant (Acomplia™) significantly improved weight, blood sugar levels and other cardiometabolic risk factors in people with Type 2 Diabetes.

Source: Diabetes In Control: sanofi aventis