Huge clinical development program of first-in-class CB1 antagonist rimonabant to show benefits beyond weight reduction and avoid image as life-style drug
BARCELONA, Spain | March 08, 2007 | The Business Intelligence firm La Merie S.L. reported today that Sanofi-Aventis’ first-in-class CB1 antagonist Acomplia (rimonabant) has at least five competitors in clinical stages up to phase III and many more in earlier phases of R&D. While Acomplia received EU approval in June 2006, the FDA requested more time to review the file. Acomplia is indicated for the treatment of patients with obesity or overweight plus cardiometabolic risk factors and achieved EU sales of € 31 mln in its first months in selected markets. However, some countries such as Germany consider Acomplia as a non-reimbursable life-style drug. Sanofi-Aventis is undertaking a huge clinical program to profile Acomplia in additional populations such as in type 2 diabetes (1st line), insulinized patients, dyslipidemia or atherosclerosis. Another field of potential use of CB1 antagonists lies in neuroscience, such as addiction and cognitive disorders. These results and more were found in a search conducted by La Merie Business Intelligence. The competitor analysis of CB1 antagonists can be acquired at www.pipelinereview.com, La Merie’s News Center and Online Store.
Rimonabant has been studied in more than 6,000 patients. Results of the RIO-LIPIDS study showed that a one-year treatment of overweight and obese patients with abnormal lipid levels with once daily rimonabant significantly reduced body weigth by an average of 6.9 kg in comparison to a loss of 1.5 kg in the placebo group. More importantly, it improved a range of cardiometabolic risk factors that may contribute to type 2 diabetes and heart disease. Results of a two-year treatment with rimonabant in the RIO- North America study evidenced sustained effects on waist circumference, body weight and cardiometabolic risk factors. Mechanism-based adverse effects associated with CB1 receptor antagonists have not been reported. Results of the SERENADE trial published in December 2006 showed that patients with type 2 diabetes not currently treated with anti-diabetic medication experienced significant improvements in glucose control and weight as well as in HDL cholesterol and triglycerides. Importantly, about 57 % of the improvements in HbA1C were independent of the weight loss achieved.
The mechanism of action of CB1 antagonists still is not yet fully understood. Data indicate a loss of appetite as well as an increase in metabolic rate and a loss of fat mass. In addition, it has been shown that cannabinoid antagonists can prevent drug reinstatement with cocaine, alcohol and nicotine. Sanofi-Aventis had studied rimonabant as an aid to smoking cessation and submitted an NDA based on studies for up to one year in over 6,500 smokers. However, the FDA issued a non-approvable letter for this indication. Studies with other molecules are ongoing to explore the utility of CB1 antagonist in the neuroscience field.
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SOURCE: La Merie Business Intelligence