A key committee of the European Medicines Agency (EMA) on April 28th recommended approval of Acomplia (rimonabant) as an aid to weight-loss, raising the prospect that the highly-anticipated drug will receive final marketing authorization from the European Commission within two to three.

"Following European marketing authorization, Acomplia will be available in European Union countries for prescription as a 20mg tablet to be taken once daily," the drug's developer Sanofi-Aventis said. "First launches are anticipated during the second half of 2006."

At the same time, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended against approval of Acomplia as an aid to smoking cessation.

The CHMP, comprised of regulators from all European Union countries, recommended granting marketing authorisation for Acomplia "as an adjunct to diet and exercise for the treatment of obese patients (BMI greater than or equal to 30), or overweight patients (BMI greater than 27) with associated risk factors, such as type 2 diabetes or dyslipidemia."

Sanofi-Aventis noted that the section of labelling approved by the CHMP stipulates that half of the improvements seen in Acomplia's clinical trials in HBA1c (an important measure of diabetic control), HDL (good) cholesterol and triglycerides were "beyond that expected from weight loss alone."

Analysts said by highlighting the improvement in serious cardiometabolic risk factors in patients taking Acomplia, the CHMP may help Sanofi to market Acomplia as more than simple weight-loss medication.

Meanwhile, Sanofi provided no further substantive news on its efforts to get Acomplia approved in the United States.

The U.S. Food and Drug Administration two months ago gave Sanofi an "approvable" letter for Acomplia, meaning that further issues need to be resolved prior to FDA action on approval. Sanofi has never elaborated on the seriousness of these issues, and said today only that discussions with the FDA are continuing.