sanofi-aventis announced that the European Commission has granted marketing authorisation for Acomplia (rimonabant 20 mg/day) in all 25 European member states. The first launch of the drug will take place in the United Kingdom in July 2006 and will be followed by launches in Denmark, Ireland, Germany, Finland and Norway during the second half of 2006.
Acomplia, discovered and developed by sanofi-aventis, is the first in a new class of drugs called CB1 blockers and is the first to be approved for the treatment of obese patients, or overweight patients with associated risk factors, such as type 2 diabetes or dyslipidaemia. The drug is indicated as an adjunct to diet and exercise for the treatment of obese patients (BMI = 30kg/m2), or overweight patients (BMI >27kg/m2) with associated risk factors.
The marketing authorisation was based on the review of comprehensive efficacy and safety data, including data from the RIO clinical trial programme which involved more than 6,600 patients worldwide, of which over 4, 500 were studied for up to two years. 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. Importantly the label granted by the European Commission states that an estimated 50 per cent of the observed improvements in HbA1c, HDL-cholesterol and triglycerides were beyond that expected from weight loss alone, said a company release.
"The approval of Acomplia in the European Union is important news for obese and overweight patients with additional cardiometabolic risk factors such as type 2 diabetes or dyslipidaemia who will now have access to an innovative treatment option," said Jean-François Dehecq, chairman and chief executive officer of sanofi-aventis".
Acomplia 20 mg is targeted at improving multiple cardiometabolic risk factors in obese and overweight patients. Those likely to gain most benefit will be patients presenting with abdominal obesity (a large waist circumference) who also have diabetes and/or dyslipidemia. Almost half the adult population with a large waist circumference (defined as 102 cm/40 inches in men and 88cm/35 inches in women) present with at least 3 additional risk factors, all contributing to increased cardiometabolic risk.
"Until now we have not had a medication that addresses the multiple cardiometabolic risk factors that put patients at risk for cardiovascular disease and type 2 diabetes," said Luc Van Gaal, M.D., Professor of Diabetology, Metabolism and Clinical Nutrition, Antwerp University Hospital, Belgium and Principal Investigator of the RIO Europe trial. "Rimonabant 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."
Acomplia will be available in European Union countries for prescription as a 20 mg tablet to be taken once daily.
The drug has been evaluated for safety in over 6,300 patients. In placebo controlled studies the discontinuation rate due to adverse reactions was 15.7 per cent for patients receiving the drug. The most common adverse events resulting in discontinuation were nausea, mood alteration with depressive disorders, anxiety and dizziness. Acompila should not be initiated in patients with hepatic or renal impairment or patients with uncontrolled serious psychiatric illnesses such as major depression.