ZimultiTreatment for Obesity
Rimonabant - Regulatory Update in Europe
The European Commission endorsed the positive opinion to extend the Summary of Product characteristics (SmPC) for Acomplia (rimonabant)
PARIS, November 13, 2007-Sanofi-aventis announced today that the European Commission endorsed the positive opinion of the European Medicines Evaluation Agency (EMEA) for Acomplia (rimonabant), to include type 2 diabetes trial results into the European label (section 5.1), based on the SERENADE study, the first rimonabant 20 mg trial to assess improvement of glycemic control in newly diagnosed naïve type 2 diabetic patients.
In this trial rimonabant 20mg significantly improved glycemic control. The absolute decrease of the HbA1c at six months was -0.8% for rimonabant 20 mg versus -0.3% for placebo (Difference -0.5%, p<0.001). 51% patients on rimonabant 20mg versus 35% in the placebo group achieved the treatment target recommended by the American Diabetes Association of an HbA1c-value below 7%. The most common adverse events leading to discontinuation for the placebo and rimonabant 20 mg patients, respectively, were nausea (0% vs. 2.2%), depressed mood disorder (0% vs. 2.2%) and paraesthesia (0% vs. 2.2%), the latter one leading to an amendment of section 4.8 of the European label.
In type 2 diabetes patients with no other treatment, rimonabant alone displayed a meaningful improvement in glycemic control. The SERENADE study demonstrated that rimonabant 20mg has additional benefits on cardio-metabolic risk factors beyond diabetes.
SERENADE (Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients) was a 6-month, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study comparing rimonabant 20 mg once daily to placebo on top of a mild hypo caloric diet in improving blood sugar control (as indicated by HbA1c) in treatment-naive type 2 diabetic patients not adequately controlled by diet alone. All patients were encouraged to increase their physical activity during the study. The study was conducted on 278 patients at 56 study centers in the United States, Germany, Argentina, Chile, Hungary, Poland and the Netherlands. The primary endpoint of the trial was change from baseline of HbA1c levels. Secondary endpoints included fasting plasma glucose, body weight, waist circumference and lipid parameters.
To be included in the trial patients had to have a diagnosis of type 2 diabetes for at least two months but less than three years, HbA1c levels greater than 7% and less than 10%, and could not have been treated previously with an anti-diabetic medication within six months prior to screening.
SERENADE is part of an extensive worldwide Phase IIIb clinical trial program involving over 25,000 patients. Eight further studies investigate the role of rimonabant in the treatment of type 2 diabetes.
About Acomplia (rimonabant)
Acomplia (rimonabant) is approved in the European Union as an adjunct to diet and exercise for the treatment of obese patients (BMI of ?30kg/m2) or overweight patients (BMI > 27kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1).1 Acomplia (rimonabant) is contraindicated in lactating patients or patients with hypersensitivity to the active substance or to any of the excipients, with ongoing major depressive illness and/or ongoing antidepressive treatment.
In pivotal clinical trials lasting up to two years, rimonabant significantly reduced body weight and waist circumference, a measure of intra-abdominal fat. Rimonabant also improved glycemic control, HDL, triglycerides (fats in the blood), and insulin sensitivity.
The most common adverse events associated with rimonabant were consistent across studies and included gastrointestinal (nausea, vomiting, diarrhea), nervous system (headache, dizziness, paresthesia/ hypoesthesia/dysesthesia) and psychiatric disorders (anxiety, insomnia, depressed mood and depression).
Rimonabant is approved in so far 52 countries and launched in 21.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY).
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Posted: November 2007
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