PARIS—The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending marketing approval in the European Union for the anti-obesity drug Acomplia.
The panel said the sanofi-aventis drug should be used in addition to diet and exercise in obese patients with associated risk factors, such as type 2 diabetes or dyslipidemia.
The recommendation to grant marketing authorization was based on the review of comprehensive efficacy and safety data. "Obesity levels in the European Union have risen significantly in the past decade in the adult population, and this represents a serious public health concern,” said Luc Van Gaal, MD, professor of Diabetology, Metabolism and Clinical Nutrition, Antwerp University Hospital, Belgium.
The European Commission usually delivers a European marketing authorization subsequent to a positive CHMP opinion within two to three months, according to sanofi-aventis. Following European marketing authorization, Acomplia will be available in European Union countries for prescription as a 20mg tablet to be taken once daily. First launches are anticipated during the second half of 2006.