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The drug Acomplia ® (Rimonabant) is allowed for sale in the EU
First in-class CB1 blocker is permitted for use in patients with obesity or overweight in the presence of associated risk factors, such as diabetes mellitus type 2, or dyslipidemia.
Paris, France, June 21, 2006 – Sanofi-aventis announced that the European Commission issued a permit to sell the drug ACOMPLIA ® (rimonabant, 20 mg / day) in all 25 European member states. The drug ACOMPLIA ®, an open and developed by sanofi-aventis, is the first in a new class of drugs called CB1 blockers. ACOMPLIA ® is recommended in addition to diet and exercise to treat obesity (BMI ≥ 30 kg/m2) or overweight (BMI> 27 kg/m2) with associated risk factors such as diabetes mellitus type 2, or dyslipidemia, where to buy zimulti .
Permission to sell the drug is issued after considering a large number of data on efficacy and safety, including clinical trial data RIO, which was attended by over 6000 patients worldwide, 4500 of these patients were examined during the biennium. RIO program results have shown that taking the drug ACOMPLIA ® tablets 20 mg daily significantly reduces body weight and waist circumference, and levels of HbA1c and triglycerides and increases HDL cholesterol. In conclusion, the European Commission said that 50% of the observed improvement in levels of HbA1c, HDL cholesterol and triglyceride levels higher than the result expected on the basis of only reduce vesa generic zimulti.
“Resolution on the use of ACOMPLIA ® in the European Union – important news for patients with obesity and overweight, with additional cardiometabolic risk factors such as diabetes mellitus type 2, or dyslipidemia. These patients now have new opportunities for treatment,” – said Jean – Francois Deek, President and Chief Executive Officer of sanofi-aventis. “Through our discovery, development, and now the resolution on the use of the drug ACOMPLIA ®, sanofi-aventis is the pelvis demonstrated its competence and commitment to creating rimonabant side effects innovative products for use by patients and physicians.”
The drug ACOMPLIA ® 20 mg is designed to reduce multiple cardiometabolic risk factors in patients with obesity and overweight. Among patients who received the drug would be particularly useful – patients with abdominal obesity (large waist circumference), and still suffering from diabetes and / or dyslipidemia. Nearly half the adult population with an increased waist circumference (more than 102 cm or 40 inches in men and 88 cm or 35 inches for women), have at least 3 additional risk factors, all of which increase the risk of buy rimonabant cardiometabolic disorders.
Overall cardiometabolic risk – is the sum of risks for diabetes mellitus type 2 and / or cardiovascular disease, it is a combination of risk factors, which can be influenced. Among the cardiometabolic risk factors include classical risk factors such as high levels of LDL cholesterol, hypertension and hyperglycemia, as well as new risk factors closely associated with abdominal obesity (especially indraabdominalnym fat deposition), such as insulin resistance, low HDL cholesterol high levels of triglycerides and inflammatory markers: adiponectin and C-reactive protein.
“So far we have not had a medicament for the impact on multiple cardiometabolic risk factors that increase the likelihood of developing cardiovascular diseases and diabetes type-2″ – said Dr. Luc Van Gaal of Medicine, Professor of Diabetology, Metabolism and Clinical Nutrition hospital, University of Antwerp (Belgium), head of the test RIO Europe. “Rimonabant – an important step forward for the treatment of multiple risk factors, the totality of which makes the risk of diabetes and cardiovascular disease. This drug has the advantage over existing methods of treatment of individual risk factors, such as high blood pressure, cholesterol and diabetes”
The drug ACOMPLIA ® will be available for appointment to the European Union in tablets of 20 mg to receive once a day. ACOMPLIA ® will be first to market with the United Kingdom purchase rimonabant in July 2006, after which the drug will do to the markets of Denmark, Ireland, Germany, Finland and Norway during the second half of 2006.
Safety and tolerability
The drug ACOMPLIA ® 20 mg tested security with the participation of over 6300 patients. In placebo-controlled studies the frequency of drug discontinuation due to adverse reactions was 15.7% in the group receiving ACOMPLIA ®. The most frequent adverse events leading to the abolition of the drug, were nausea, mood changes with depressive disorders, anxiety and golovokruzhenie.1
The drug ACOMPLIA ® should not be used in patients with hepatic impairment or kidney disease, as well as with untreated mental illness, for example, expressed depressii rimonabant tablets.
On the drug ACOMPLIA ®
The action of the drug ACOMPLIA ® is based on a selective blockade of CB1 receptors, localized in the brain and peripheral organs and play an important role in the exchange of fat, including adipose tissue, liver, gastrointestinal tract and myshtsah.2 blockade of CB1 receptors reduces the drug ACOMPLIA ® excessive activity endokannabinoidnoy systems (EC) .3, 4 EC system – is a newly described physiological system that includes elements such as the CB1 receptors, suggest that this system plays an important role in regulating body weight and energy balance, as well as exchange glucose and fat.
About sanofi-aventis
Sanofi-aventis – the third largest in the world’s leading pharmaceutical company. Due to its large-scale research development, 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 New York (NYSE: SNY) stock exchanges.
Forward Looking Statements
This press release contains statements that are forward-looking statements within the meaning of the Act (1995) on the back of securities. Forward-looking statements – statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations for future operations, products and services, as well as statements regarding future performance. Forward-looking statements are generally identified by the words “expects,” “anticipates,” “believe,” “intend,” “estimate,” “plans” and similar expressions. Despite the fact that the leadership of the slimona rimonabant 20 mg sanofi-aventis believes that the expectations reflected in such statements are reasonable, investors are cautioned that forward-looking information and statements are subject to risks and uncertainties, which are difficult to predict and generally beyond the control of sanofi-aventis. As a result, actual results and developments may differ materially from those assumed or described in the information or statements. These risks and uncertainties include those discussed or identified in the public filings uncertainties include those discussed or identified in the public documents sent by sanofi-aventis, the Commission on the U.S. Securities and Exchange (SEC) and the Department of Financial Markets of France (AMF), including those listed in under “Risk Factors” and “Cautionary Statement Regarding Forward Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2004, except as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking statements.
