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April 2007
Acomplia is Approved in Brazil for the Treatment of Obese Patients
April 27, 2007
Acomplia (rimonabant)
is Approved in Brazil for the Treatment of Obese Patients,
or Overweight Patients with Associated Risk Factors, Such
as Type 2 Diabetes or Dyslipidemia
PARIS - April 26, 2007 - Sanofi-aventis announced today
that the ANVISA, the Brazilian Health Authority, has granted
marketing authorisation for Acomplia (rimonabant), in the
following indication:
Acomplia is indicated as an adjunct to diet and exercise
for the treatment of obese patients (Body Mass Index - BMI
above or equal to 30 kg/m2), or overweight patients (BMI
above 27 kg/m2) with associated risk factors, such as type
2 diabetes or dyslipidemia.
Acomplia
is the first member of a new therapeutic class: the CB1
receptor antagonists. The marketing authorisation is based
on a thorough analysis of the extensive safety and efficacy
results and the assessment of the pivotal clinical trial
program of the phase III. These results have shown that
Acomplia at 20 mg per day (1 tablet) significantly reduces
weight, waist circumference, HBA1c, triglycerides, at the
same time improving significantly the patients’ HDL
("good cholesterol").
About sanofi-aventis
Sanofi-aventis is one of the world leaders in the pharmaceutical
industry, 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 (EURONEXT: SAN)
and in New York (NYSE: SNY).
Source: - http://www.medadnews.com