Acomplia SERENADE Data Is Music To Sanofi’s Ears
This article was originally published in The Pink Sheet Daily
Executive Summary
Results of the study of rimonabant in type 2 diabetes patients shows improvements in blood sugar, weight and other risk factors.
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A study of Sanofi-Aventis' investigational drug Acomplia (rimonabant) in patients with type 2 diabetes showed that the drug improved blood sugar control and weight, as well as other risk factors such as HDL-cholesterol and triglycerides compared to placebo. Sanofi presented results of SERENADE at the International Diabetes Federation World Diabetes Congress in Cape Town, South Africa Dec. 5. The data could help strengthen Sanofi's case for approval of Acomplia for claims such as metabolic syndrome, a condition that covers obesity plus high cholesterol, high blood pressure and insulin resistance. The company's NDA for Acomplia for weight loss is currently pending at FDA after Sanofi submitted a response Oct. 26 to an FDA "approvable" letter. The firm announced it had responded to FDA's concerns without conducting additional clinical trials during its third quarter call (1 ). In February, FDA issued an approvable letter for a weight loss indication for Acomplia, but deemed the drug "not approvable" for a smoking cessation indication (2 (Also see "Acomplia Is "Not Approvable" For Smoking Cessation, "Approvable" For Weight Loss" - Pink Sheet, 17 Feb, 2006.)). "The treatment of type 2 diabetes should not only focus on controlling blood sugar levels, but also improve other risk factors, such as weight, good and bad cholesterol, triglycerides and blood pressure," study investigator Julio Rosenstock (University of Texas Southwestern Medical School) stated. SERENADE looked at treatment-naive type 2 diabetes patients who received rimonabant 20 mg per day over six months. Results showed that patients treated with Acomplia lowered their HbA1C levels by 0.8% from a baseline value of 7.9 compared to a reduction of 0.3% in placebo arm (p=0.002). In addition, among patients with an A1C level greater than or equal to 8.5% at baseline, levels were significantly reduced with Acomplia by 1.9% compared to 0.7% with placebo (p=0.0009). Over 50% of patients achieved A1C levels below 7%, the target for glucose control recommended by the American Diabetes Association. Improvements in blood glucose were accompanied by reductions in body weight of 14.8 lbs in patients in the treatment group compared with 5.95 lbs in patients on placebo. In addition, HDL cholesterol increased by 10.1% in the treatment arm compared to 3.2% for patients on placebo. Triglyceride levels decreased by 16.3% compared to a 4.4% increase for placebo. Acomplia is already available in the European Union, where it received marketing authorization for the treatment of obesity in June; the drug was approved as an adjunct to diet and exercise for the treatment of obese patients or overweight patients with risk factors such as type 2 diabetes (3 (Also see "Acomplia To Launch In July In Europe For Obesity Indication" - Pink Sheet, 21 Jun, 2006.)). Acomplia has demonstrated statistically significant improvements in lowering patients' cholesterol levels, triglyceride levels and blood pressure in Phase III trials before, including the RIO-Lipids study released in 2004. SERENADE is part of a series of trials underway, including ADAGIO in patients with abdominal obesity and dyslipidemia; ARPEGGIO in insulinized patients; RAPSODI in prediabetic patients; and STRADIVARIUS and AUDITOR in patients with atherosclerosis. - Jessica Merrill ([email protected]) |