Acomplia is specifically indicated as an adjunct to diet and exercise for the treatment of obese or overweight patients with associated risk factors, such as type 2 diabetes or dyslipidaemia. The drug will now be available in European Union countries for prescription as a 20mg tablet to be taken once daily.
The marketing authorization was based on the review of comprehensive efficacy and safety data, including data from the RIO clinical trial program which involved more than 6,600 patients worldwide, of which over 4,500 were studied for up to two years.
Results from the RIO program demonstrated that one Acomplia 20mg tablet taken every day significantly decreased weight and waist circumference, HbA1c, and triglycerides and increased HDL-cholesterol levels.
Importantly the label granted by the European Commission states that an estimated 50% of the observed improvements in HbA1c, HDL-cholesterol and triglycerides were beyond that expected from weight loss alone.
“Rimonabant (Acomplia) is an important advance to treat the multiple risk factors which contribute to the global risk for diabetes and cardiovascular disease, which will offer benefits beyond current treatments for individual risk factors such as blood pressure, cholesterol and diabetes,” said Dr Luc Van Gaal, professor of diabetology, metabolism and clinical nutrition, Antwerp University Hospital, and principle investigator in the RIO Europe trial.