The European Commission has decided to let Sanofi-Aventis inform patients taking diet drug Acomplia (rimonabant) that the pill may also help in diabetic blood sugar control, but that does not mean it is approved to be prescribed as a diabetes drug.
The announcement, which ratified an earlier decision by the European Medicines Agency (EMEA), means only that Sanofi can include news of results from a small phase IIIb trial on the insert that is included ib packages of Acomplia sold in European Union countries.
The current prescribing indications, approved by the European Commission in the summer of 2006, authorize use of Acomplia in Europe as an adjunct to diet and exercise for treatment of obese patients or overweight patients with associated risk factors such as type 2 diabetes or dyslipidaemia.
The drug is not approved for sale in the United States, where Sanofi had hoped to sell it as Zimulti, and the company pulled back its application after an FDA advisory panel expressed concern over rimonabant's depressive and suicidal side-effects..
But Sanofi has said it hopes, based on eight trials now underway, to submit Acomplia for worldwide approval as a treatment for type 2 diabetes in 2009, and the European decision to allow inclusion of results from a diabetes trial on the insert suggests more off-label use of the drug to treat diabetes may occur in the meantime.
The results come from the so-called SERENADE trial, which compared use of Acomplia to improve blood sugar control (as indicated by the patient's HbA1c level, a measure of glucose control) in 276 newly diagnosed type 2 diabetic patients who had not yet been treated with any diabetes drug.
In the trial, researchers said those taking rimonabant saw an average decrease in their HbA1c level of 0.8 compared to 0.3 for those on a placebo, with 51 percent of those on rimonabant achieving the treatment target level recommended by the American Diabetes Association.