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Sanofi Hoping Acomplia Will Be Approved in Europe for Treating Diabetes

While diet drug Acomplia / Zimulti (rimonabant) seems unlikely to make it to the U.S. market for at least a couple of years, Sanofi-Aventis appears hopeful the pill -- which already is on sale in Europe -- may soon be approved there for treatment of type 2 diabetes.

Executive Vice President Hanspeter Spek, talking to financial analysts on Aug. 1st, said the European Medicines Agency (EMEA) "is reviewing the data" from the SERENADE study in which diabetics not treated with other diabetic medications experienced significant improvements in blood sugar control.

In the study, blood sugar levels of half of the patients on Acomplia fell to below 7 percent -- the target set by the American Diabetes Association for good glucose control -- and the patients taking Acomplia lost almost 15 pounds of weight compared to 6 pounds for those on a placebo.

The trial showed that HbA1c levels (a measure of blood glucose) in patients with a baseline average of 7.9 who took a 20 mg Acomplia pill once daily fell 0.8 percentage points compared to a drop of 0.3 points in those taking a placebo.

Patients with an HbA1c level of at least 8.5 when they started taking Acomplia saw their their blood sugar level decrease 1.9 points compared to 0.7 points in patients on a placebo.

Results of the study were submitted to both the FDA and the EMEA earlier this year in hopes that both might approve use of the drug for treating diabetes as well as for weight control.

The EMEA approved Acomplia more than a year ago as an aid to weight loss in obese patients and overweight patients with type 2 diabetes or other risk factors. Despite safety concerns that led to withdrawal of Sanofi's application to market Zimulti in the U.S., the EMEA decided to permit its continued sale.

"The overall [EMEA] review of SERENADE in respect to the usage of the product in diabetes patients is still ongoing, and we cannot report anything else," Spek said.

"We do not know what comes out of it, and we don't know when the EMEA will express how they see SERENADE in respect to a potential enlargement of the indication here in Europe," Spek added.