Acomplia (rimonabant) is Now Officially Reimbursable in France, for the Treatment of Eligible Obese and Type 2 Diabetic PatientsPARIS, March 22, 2007 - Sanofi-aventis announced today that Acomplia® 20mg (rimonabant), the first drug in a new therapeutic class, the selective cannabinoid-1 receptor antagonists, has now been included in the list of pharmaceutical products reimbursable by the Social Security, by virtue of a decree dated March 22, 2007, published in the Official Journal of the French Republic.
Acomplia® is now reimbursable(1) for obese patients (body mass index equal to or greater than 30kg/m2) with Type 2 diabetes uncontrolled by monotherapy with metformin or a sulphonylurea, and whose HbA1c is in the range of 6.5%-10%. Treatment with Acomplia® should be an adjunct to diet and physical activity.
For these patients Acomplia® has a two-fold action: reduction in weight and waist circumference, and an improvement of the glucose and lipid metabolism.
There is no alternative medication to Acomplia® on the list of reimbursable drugs. Acomplia® will be available in pharmacies at a public price of 71.63 euros, including tax, for a 28 day course.
(1) To be entitled to the 35% Social Security reimbursement the prescription must be issued on a special form (ordonnance de médicament d’exception) and conform to the details laid out in the Therapeutics Information Bulletin.
On the 19th June 2006, marketing approval was granted to Acomplia® by the European Commission for the treatment of obese patients (BMI equal to or greater than 30kg/m2), or those overweight (BMI greater than 27 kg/m2) with associated risk factors such as Type 2 diabetes or dyslipidaemia, in conjunction with diet and physical exercise.
Beyond that, the label granted by the European Commission states that an estimated 50% of the improved figures observed regarding the levels of HbA1c, HDL cholesterol and triglycerides was independent of that expected from weight loss alone. The lipoprotein fraction significantly enhanced by rimonabant is called “HDL” (HDL: high density lipoprotein), also referred to as “good cholesterol”.
Sanofi-aventis is one of the world leaders in the pharmaceutical industry, 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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Posted: March 2007
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