Zimulti
rimonabant
Treatment for Weight LossFDA Advisory Committee Did Not Recommend Approval of Rimonabant (Zimulti) for Use in Obese and Overweight Patients With Associated Risks Factors
PARIS, June 13, 2007 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee did not recommend approval of rimonabant (Zimulti) to the US FDA for use in obese and overweight patients with associated risks factors.
Sanofi-aventis will continue to work closely with the FDA to address the committee's recommendations.
The FDA has set a PDUFA action date of July 26, 2007 for rimonabant.
Rimonabant is currently approved in 37 countries and is marketed in 18. In those countries where it is currently sold, the product is marketed as Acomplia.
About Rimonabant
Rimonabant is the first and the most studied member of a new therapeutic class of drugs that selectively block the CB1 receptors of the endocannabinoid system (ECS), and the drug's development has deepened scientists' understanding of the ECS. When working normally, this system of receptors in the brain and throughout the body (liver, muscle, abdominal adipose tissue, gastro-intestinal tract and pancreas), among other functions, helps regulate food intake and how the body uses and stores fats and sugars.
Rimonabant, and its effects on the ECS, have been extensively studied, resulting in well-defined efficacy and safety profiles. The Committee reviewed findings from a comprehensive clinical trials program that included data from 59 completed clinical studies enrolling more than 15,000 patients.
Additional safety data were presented from ongoing clinical studies and more than 110,000 individuals in Europe and other countries who have taken rimonabant.
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). These adverse events generally occurred within the first 2-3 months, and were often mild to moderate in intensity.
About sanofi-aventis
Sanofi-aventis is one of the world's leading pharmaceutical companies, ranking number one in Europe. Backed by a world-class R&D organization, 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 and in New York .
Forward Looking Statements
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defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include financial projections
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regarding plans, objectives, intentions and expectations with
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reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of sanofi-aventis, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward- looking information
and statements. These risks and uncertainties include those
discussed or identified in the public filings with the SEC and the
AMF made by sanofi-aventis, including those listed 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, 2006. Other than as required by applicable
law, sanofi-aventis does not undertake any obligation to update or
revise any forward-looking information or statements.
US Media Relations:
Julissa Viana: +1 908-981-6575 / Email: julissa.viana@sanfoi-aventis.com
Lisa Kennedy: +1 908-981-6569 / Email: lisa.a.kennedy@sanofi-aventis.com
CONTACT: US Media Relations, Julissa Viana, +1-908-981-6575,, or Lisa Kennedy, +1-908-981-6569,, both of sanofi-aventis julissa.viana@sanfoi-aventis.com lisa.a.kennedy@sanofi-aventis.com
Web site: http://www.sanofi-aventis.us/http://www.sanofi-aventis.com//
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Related Articles:
Rimonabant - Regulatory Update in Europe - November 14, 2007
Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Acomplia/Zimulti - July 19, 2007
Rimonabant Regulatory Update in the United States - June 29, 2007
Weight Loss Drug Rimonabant Can Cause Serious Physical and Psychological Harm and Birth Defects, Public Citizen Tells FDA - June 14, 2007
Rimonabant USA: Update - March 26, 2007
Sanofi-aventis Acknowledges FDA Announcement of an Advisory Committee Meeting for rimonabant - March 26, 2007
Rimonabant USA: Update - February 12, 2007
Rimonabant Update in the United States - December 8, 2006
Sanofi-aventis Received from the FDA an Approvable Letter for Rimonabant for Weight Management and a Non Approvable Letter for Smoking Cessation - February 17, 2006
Rimonabant Accepted for Filing By the FDA - June 23, 2005
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