Sanofi-Aventis reports CHMP approval for new Acomplia labelling

Sanofi-Aventis has announced that the European Committee for Medicinal Products for Human Use (CHMP) has conducted a re-evaluation and consequently approved the labelling update of Acomplia (rimonabant) in Europe.

This CHMP has also affirmed the positive benefit-risk profile of the compound in the indicated patient population – those not suffering from ongoing major depression.

Changes to the label for Acomplia follow a year of post-marketing experience of the drug, primarily in the UK, France and Germany, in addition to the results of five further clinical trials.

Acomplia is currently approved in the European Union as a treatment for obese patients with a BMI equal or greater than 30 kg/square metre and overweight patients with a BMI of greater than 27 kg/square metre with type two diabetes or dyslipidemia.

The treatment is administered in conjunction with physical exercise and diet.

“With this updated labelling, Acomplia is now contraindicated in patients with ongoing major depressive illness and/or ongoing anti-depressive treatment,” Sanofi-Aventis reports.

It adds that the special warnings and precautions section of its summary of product characteristics have also been updated to include this information, with a letter sent to doctors informing them of these changes in the European countries where the compound is marketed.

In April 2007, Sanofi-Aventis announced that Acomplia had been approved for use in Switzerland for use in obese patients at risk of developing cardiovascular illnesses.