Status Info

Has Rimonabant use been approved in Europe? - YES

In June 2006, the European Commission granted authorisation for Sanofi Aventis to market Rimonabant under the name of Acomplia throughout the 25 then member states of the European Union.  Acomplia first went on sale within the United Kingdom in July 2006. It is prescribed as a weight loss aid for patients classed as obese (those with a BMI of ≥ 30) or overweight (those with a BMI > 27) with linked risk factor(s), such as type 2 diabetes or dyslipidaemia. By January 2007 it was also available in Germany, Denmark, Sweden, Finland, Norway, Ireland and Austria.

Has Rimonabant use been approved in the United States? - NO

Despite the excitement initially generated over the scientific findings that Rimonabant aided weight loss the FDA (Food and Drug Administration) are yet to approve the drug within the United States.  Sanofi Aventis proposed to market Rimonabant as Zimulti within the US with hopes that it could be a $3 billion seller.  However, the FDA's advisory panel, the EMDAC (Endocrinologic and Metabolic Drugs Advisory Committee) voted against approving the drug as safe for use on June 13, 2007. Later that month, on June 29th Sanofi Aventis withdrew their New Drug Application and issued an accompanying statement saying they will enter into discussions with the FDA to determine what modifications are deemed necessary for their file to be reconsidered with a view to resubmitting the drug's application at a future date.

Why did the EMDAC refuse to recommend approval of Rimonabant?

The EMDAC´s decision was based upon research results which indicated that the use of Rimonabant could lead to numerous side effects. Most notably, suicidal thoughts and actions.  Read more...

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