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Sanofi-Aventis pulled its NDA in the United States

The highly-debated anti-obesity drug Acomplia would not be marketed in the U.S as the French drug maker Sanofi-Aventis finally pulled its New Drug Application (NDA) back after facing severe criticism on the ground of psychiatric adverse effects.

Acomplia, also eminent as rimonabant, has been touted as a breakthrough innovation for the treatment of obesity right from its inception, but all its craze faded out with the release of the US Food and Drug Administration (FDA) advisory committee’s report rebuffing to endorse the drug for sale in the U.S. on the basis of high frequency of psychiatric adverse events..

The pharmaceutical giant now has pulled its NDA in the US. While the maker is confident about its drug’s US presence in the near future, analysts estimated that the drug would not be launched in the U.S. for at least next two to three years.

Meanwhile, the acomplia’s fate in the E.U. is in the hands of the European Medicines Agency's (EMEA) as the agency recently pronounced that the Committee for Medicinal Products for Human Use (CHMP) will carry on the review of the drug's safety. The CHMP conclusions will be released by July 19.The CHMP will review the available data in relation to the drug’s psychiatric side effects, particularly suicidal ideation and depression-related events

“The result of the committee’s review would recommend one out of the numerous regulatory options, including no modifications in to marketing, addition of additional cautions, deferral of the drug until more relevant data is provided, or complete withdrawal of the product from the market”, said EMEA spokeswoman Monika Benstetter.

Benstetter had not articulated how the FDA advisory committee's verdict might affect the review, yet it is sure that the EMEA would contemplate the committee's concerns.  

So, NDA withdrawal may give a heavy blow to Sanofi’s niche in the European anti-obesity market, wherein Acomplia is available since June, 2006.