A European regulatory review of diet drug Acomplia (rimonabant) may result in publication of new safety recommendations as early as June 29th, accordilng to a spokesperson for the European Medicines Agency (EMEA).
The EMEA said it anticipates that comments of Acomplia will be included in the monthly report of its drug safety committee which is due out on Friday.
The European review of Acomplia was triggered by the overwhelming vote of the U.S. Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee earlier this month recommending against sale of the diet drug in the United States based on currently available safety date.
Acomplia is now widely available in Europe, where the diet drug was approved by the EMEA more than a year ago, and has been purchased by more than 100,000 Europeans.
However, the U.S. advisory panel’s vote was based on newer data than that available to the EMEA a year ago — including data from post-marketing reports on usage in Europe.
While Acomplia remains on sale in European Union countries for the moment on the same basis as it has been for the past year, the EMEA may reinforce warnings about side effects associated with the drug, including depression and suicidality.
Approval of rimonabant for sale in the United States, where it was to be marketed as Zimulti, now is not expected until additional data from the large CRESCENDO trial becomes available in another two or three years.
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