Sanofi-Aventis has withdrawn Acomplia from the European markets following an EMEA recommendation that the company suspend sales of the drug due to safety concerns. The anti-obesity drug was approved in the EU in 2006 but never managed to capture an FDA approval because the agency was concerned that Acomplia increased incidents of suicidal behavior and depression among patients. In reviewing post-marketing data on the drug, the EU's Committee for Medicinal Products for Human Use found that Acomplia doubled the risk of psychiatric disorders in obese or overweight patients taking the drug.
"The CHMP considered that the new data from post-marketing experience and ongoing clinical trials indicated that serious psychiatric disorders may be more common than in the clinical trials used in the initial assessment of the medicine. The CHMP was also of the opinion that these psychiatric side effects could not be adequately addressed by further risk minimisation measures. In addition, the CHMP noted, that the effectiveness of Acomplia in clinical practice is more limited than was expected on the basis of the clinical trials, because available data indicate that patients generally take Acomplia only for a short period," the EMEA said in a statement.
Sanofi said it's cooperating with the EMEA and will discuss the best course of action with regulators in non-EU countries that have approved the drug. Acomplia was once one of Sanofi's brightest hopes, with a projected market of $5 billion by 2010. The drug did just $112 million in sales last year.
- see the EMEA's recommendation
- here's Sanofi's response
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