FDAnews Drug Daily Bulletin

SANOFI-AVENTIS GETS EUROPEAN APPROVAL FOR ACOMPLIA

July 3, 2006
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The European Commission (EC) has granted marketing authorization for sanofi-aventis' Acomplia in all 25 European member states, making it the first of a new type of drugs to be approved to treat obesity, the company said.

Acomplia belongs to a new class of drugs called CB-1 blockers, working to decrease overactivity of the endocannabinoid system, which is believed to play a key role in regulating body weight and glucose and lipid metabolism. It is indicated for the treatment of obese patients or overweight patients with associated risk factors, including Type 2 diabetes or dyslipidaemia.

The once-a-day Acomplia tablets will first launch in the United Kingdom in July 2006, with subsequent launches in Denmark, Ireland, Germany, Finland and Norway.