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Sanofi-Aventis said the European Commission has endorsed a positive opinion from the European Medicines Evaluation Agency (EMEA) for its Acomplia drug to carry type 2 diabetes trial results on its European label instructions.

In September, Sanofi announced it aims to submit Acomplia, generic name rimonabant, for worldwide approval in 2009 as a treatment for type 2 diabetes.

The results are based on the 'Serenade' trial, which compared 20 mg once daily to placebo in improving blood sugar control in type 2 diabetic patients new to treatment and whose weight was not adequately controlled by diet alone for a period of six months.

It said in the trial that rimonabant 20mg significantly improved glycemic control, achieving the treatment target recommended by the American Diabetes Association of an HbA1c-value for blood sugar of below 7 pct.

Rimonabant has already been approved by the EU with an indication for treating obesity, and is now on sale in a number of European countries.

But in the US, the company expects a four-year delay before gaining approval for the drug for which it withdrew its new drug application after trials revealed possible risks for patients suffering from depression.

In the Serenade trial, Sanofi said 2.2 pct of patients ceased treatment due to depressed mood disorder, compared to none for the placebo.

It said the Serenade study also demonstrated that rimonabant 20mg has additional benefits on cardio-metabolic risk factors beyond diabetes.

http://www.acomplia.p5.org.uk