The authorities have granted registration for Acomplia as an adjuvant to diet and exercise in obese and overweight patients for those with diabetes and in combination with conventional treatments such as metformin or sulfonylurea.
The main risk factors are abdominal obesity, bad cholesterol, low good cholesterol, insulin resistance, elevated glucose and high blood pressure.
The approval of Acomplia was based on efficacy and safety data from a clinical trial program. Results demonstrated that one Acomplia tablet taken everyday significantly decreased weight, waist circumference and increased good cholesterol.
Cardiovascular disease and type 2 diabetes are Mexico’s first and second causes of death.
Acomplia is yet to receive marketing approval in the US but is already prescribed in several European countries. Sanofi-Aventis plans to launch the drug in the US this year.