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Monday, November 9 - 2009

European Commission supports EMEA to extend indications for Acomplia

  • United Arab Emirates: Sunday, December 09 - 2007 at 11:30
  • PRESS RELEASE

The European Commission endorsed the positive opinion of the European Medicines Evaluation Agency (EMEA) for Acomplia (rimonabant) to include type 2 diabetes trial results in the European Label.

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The support shown from the European Commission and EMEA is based on the Serenade study showing an improvement in blood sugar control in newly diagnosed type 2 diabetic patients using rimonabant 20mg.

Despite new therapeutic advances, more than 180 million people worldwide have diabetes and this number is likely to more than double by 2030. Approximately 1.1 million people died from diabetes in 2005 and the WHO projects that diabetes deaths will increase by more than 50% in the next 10 years without urgent action. Most notably, diabetes deaths are projected to increase by over 80% in upper-middle income countries between 2006 and 2015.

"We all know that the UAE has one of the highest rates of type 2 diabetes in the world, but there is an additional 18% of the UAE's population that is suffering from impaired glucose tolerance that will surely develop into diabetes," said Dr. Micheal Khouri, Consultant Cardio-Interventionist, Sheikh Khalifa Medical City, Abu Dhabi.

"Rimonabant is already prescribed to patients that suffer from cardio-metabolic risk factors such as abdominal obesity with high blood pressure, and dyslipidenia, having it with the new indication for prescription to newly diagnosed diabetic patients will provide a significant impact in Type II diabetes management."

Acomplia is indicated for the treatment of abdominally obese patients with cardio metabolic risk clusters. Researchers at the American Diabetes Association's 65th Annual Scientific Session, reported that the drug, approved by the European Medicines Evaluation Agency (EMEA), improves blood lipid levels, reduces blood pressure, weight and waist circumference.

The recent Serenade study shows that 51% of patients on rimonabant 20mg achieved the treatment target (HbA1c - value below 7%) recommended by the American Diabetes Association, versus the 35% of patients in the placebo group.

"Rimonabant is already the first in the new drug class called CB1 blockers which helps in the management of cardio-metabolic risks," says Dr. Hisham Mahmoud, Head of Medical Department, Sanofi-aventis pharmaceuticals, Dubai. "This study will expand Acomplia's portfolio of indications, it will also drive Acomplia to be one of the main treatments for type II diabetes."
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Notes and media contacts

About Acomplia
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).

For media enquiries, please contact:

Dalia Aziz
Snofi-aventis Pharmaceuticals
Office +971 4 4299202
Mobile +97150 6569940

For Further Information, Please Contact:
Zeina El-Hakam/Aileen Culligan
ASDA'A Public Relations - Dubai
Exclusive Affiliate of Edelman PR Worldwide in the Middle East & North Africa
www.asdaa.com
T: +971 4 3355 969
F: +971 4 3356 080

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