French drugmaker sanofi-aventis has announced that the European Commission (EC) has granted marketing authorization for Acomplia (rimonabant 20 mg/day) in all 25 European member states. The first launch of the drug will take place in the UK in July, and will be followed by launches in Denmark, Ireland, Germany, Finland and Norway during the second half of 2006.
Acomplia 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 or overweight patients with associated risk factors.
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.