Sanofi's Acomplia gets EU marketing clearance; hopes US appro not far behind

French drug major Sanofi-Aventis has been granted marketing authorization for Acomplia (rimonabant 20mg/day) in all 25 member states of the European Union. The agent, which is the first in a new class of drugs called CB1 blockers, is 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.

News of Acomplia's approval came on June 21 and sent the company's share price up 1.5% to $46.31. The Paris-headquartered firm, which is the world's third-largest by sales, said that the once-daily oral drug will be launched in the UK in July, followed by market introductions in Denmark, Ireland, Germany, Finland and Norway during the second half of the year.

The marketing authorization was based on the review of comprehensive efficacy and safety data, including that from the 6,600-patient RIO program, which demonstrated that one 20mg Acomplia tablet taken every day significantly decreased weight and waist circumference, HbA1c and triglycerides, as well as raising high-density lipoprotein-cholesterol levels.