Sanofi-aventis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending to grant marketing authorisation in the European Union for ACOMPLIA® (rimonabant 20mg) for the following indication: “ As an adjunct to diet and exercise for the treatment of obese patients (BMI ≥ 30kg/m2), or overweight patients (BMI > 27 kg/m2) with associated risk factors, such as type 2 diabetes or dyslipidemia. Clinical study results stipulate that half of the observed improvements in HbA1c, HDL cholesterol and triglycerides were beyond that expected from weight loss alone.
ACOMPLIA®, a first-in-class selective CB1 blocker, has been discovered and developed by
sanofi-aventis.
The CHMP, comprised of regulators from all European Union countries, gave its positive opinion following a timely one-year review of the ACOMPLIA® application. The recommendation to grant marketing authorization was based on the review of comprehensive efficacy and safety data, including data from the RIO clinical trial program which involved more than 6,600 patients worldwide, studied for up to two years, where it has been demonstrated that rimonabant 20mg/day significantly improved weight and waist circumference, HbA1c, HDL cholesterol and triglycerides.
“Patients who suffer from abdominal obesity are at a major risk for cardiovascular disease, which is the leading cause of death worldwide,” said Dr. Wael Almahmeed, Vice President of Emirates Cardiac Society. “Acomplia’s recommendation by the CHMP could give a new lease of life to overweight patients with associated risk factors.”
“Obesity levels in the European Union have risen significantly in the past decade in the adult population, and this represents a serious public health concern. Specifically, those with abdominal obesity are at the greatest risk of developing type 2 diabetes and heart disease, due to the link between abdominal obesity and other risk factors , ” said Luc Van Gaal, M.D., Professor of Diabetology, Metabolism and Clinical Nutrition, Antwerp University Hospital, Belgium and Principal Investigator of the RIO Europe trial.
“ACOMPLIA® is an innovative, first-in-class treatment which will offer physicians a new approach to managing multiple cardiometabolic risk factors in patients with abdominal obesity who have other conditions such as type 2 diabetes, or unhealthy lipids. We should only use this drug in such patients where there is a real medical need, and not in people who may seek to use it for cosmetic reasons,” he added.
Following completion of the phase III program for rimonabant, sanofi-aventis has embarked on the next chapter in the clinical development of ACOMPLIA®. An extensive program, consisting of a large number of studies including more than 22,000 patients has been designed to further investigate the impact of rimonabant on cardiometabolic disease.
The European Commission usually delivers a European marketing authorization subsequent to a positive CHMP opinion within two to three months. Following European marketing authorization, ACOMPLIA® will be available in European Union countries for prescription as a 20mg tablet to be taken once daily. First launches are anticipated during the second half of 2006.
The CHMP has not adopted a positive opinion for ACOMPLIA® in smoking cessation.
About ACOMPLIA®
ACOMPLIA® acts by selectively blocking CB1 receptors found in the brain and in peripheral organs important in glucose and lipid (or fat) metabolism, including adipose tissue, the liver, gastrointestinal tract and muscle. CB1 receptor blockade with ACOMPLIA® acts to decrease the overactivity of the endocannabinoid system (EC system). , The EC system is a recently characterised physiological system that includes receptors such as the CB1 receptor and it has been shown to play an important role in regulating body weight and in controlling energy balance, as well as glucose and lipid (or fat) metabolism.
About sanofi-aventis
Sanofi-aventis is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organisation, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Forward-Looking Statements
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