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Drug Development

Acomplia recommended for approval in the European Union

Published in Obesity and Diabetes Week, June 5th, 2006

Sanofi-aventis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending to grant marketing authorization in the European Union for Acomplia (rimonabant 20mg) as an adjunct to diet and exercise for the treatment of obese patients (BMI{{>=}}30kg/m2), or overweight patients (BMI>27 kg/m2) with associated risk factors, such as type 2 diabetes or dyslipidemia.

The CHMP, comprised of regulators from all European Union countries, gave its positive opinion following a timely 1-year review of the Acomplia application. The recommendation to grant marketing authorization was...

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