-         Sanofi Aventis –

Sanofi Aventis decided to withdraw its application of the new anti-obesity medication Acomplia (rimonabant) for the approval of the U.S. Food and Drug Administration. Though Acomplia, which is also known as Zimulti, is now approved in the entire European Union, it is unlikely to enter the market of the United States, at least in the nearest two or three years.

The FDA started reviewing the rimonabant application from Sanofi Aventis in 2005, but in a year it declined the final decision on approving the medication in view of certain concerns referring safety of the new drug. Now the company itself reported about taking its application to the FDA back.

Though the official press-release, issued by Sanofi Aventis on June 29, 2007, underlines the confidence of the company in the positive risk\benefit ratio of rimonabant provided that it is prescribed and used properly, some experts say that there were certain psychiatric side effects, and suicidal behavior in particular, which became the reason for the advisory committee not to recommend the FDA to approve this medication on the territory of the United States.     

Rimonabant was developed by the Sanofi Aventis as a completely new therapeutic approach to the treatment of overweight and obesity in patients with associated risk factors, such as diabetes or increased cholesterol. The mode of action of rimonabant is based on its ability to block the receptors of the so-called endocannabinoid system. Those receptors can be found all around the whole human body, including brain, liver, muscles, pancreas and gastro-intestinal tract, where they participate in the process of food intake regulation. The same receptors also tell the body how to use and store the consumed fats and sugars.

The conducted clinical studies showed that rimonabant can help people lose weight, increase the “good” cholesterol level and decrease triglycerides. However, the studies also indicated that about 26% of patients, treated with rimonabant 20 mg experienced psychiatric side effects (two persons even committed suicide).

Rimonabant, which is now available in the EU under the brand names Acomplia or Zimulti, was aimed to become a serious rival for the older anti-obesity medications, such as Xenical or Meridia. And it did become a competitor, generating 31 million euros in net sales in 2006.

While the USA market still remains on lock for rimonabant, its position on the EU market is also questioned. For the time being, Acomplia is approved in 42 countries, but the European Medicines Agency continues reviewing the drug’s safety.

The conclusion of the European experts is expected later this summer. Depending on the character of that decision rimonabant status may be changed: probably, the new warning will be added, or the sales of this drug will be suspended till the additional data arrive. Of course, such options as complete withdrawal of the medication from the market or no changes to its status at all should not be excluded as well.

Meanwhile, the patients in the USA have recently received one more option to fight obesity – the FDA approved Alli – the first over-the-counter diet pill, which is, in fact, the “light” version of Xenical. Alli contains the same working ingredient as Xenical but its concentration is reduced for 50%.

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External resources
http://www.in-pharmatechnologist.com/news/ng.asp?n=77831-sanofi-aventis-emea-...
http://www.epillz.com/info/acomplia-enters-north-america.html
http://www.epillz.com/info/rimonabant.html
http://en.sanofi-aventis.com/press/p_press.asp

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