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news.Sanofi-Aventis has announced that the European Medicines Agency has recommended to the European Commission the temporary suspension of the marketing authorization of Acomplia for the approved indication of overweight and obese patients.
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Since the start of the commercialization of Acomplia, Sanofi-Aventis said that it has been closely collaborating with both the regulatory authorities and healthcare providers to monitor on an ongoing basis the real life use of the product and to ensure its use in the right patient population.
Sanofi-Aventis believes that Acomplia will remain an important therapeutic answer to a highly prevalent and increasing unmet medical need. As discussed with the European Medicines Agency (EMEA), Sanofi-Aventis said that it will continue the ongoing clinical trial program except Phase IV and is committed to provide additional evidence for the positive re-evaluation of the benefit/risk profile of Acomplia, including through studies in diabetes and in patients at risk of cardiovascular disease.
Inline with its commitment to the EMEA, Sanofi-Aventis said that the company and its subsidiaries will inform healthcare professionals the temporary marketing authorization suspension.
Sanofi-Aventis added that it will immediately enter into discussions with healthcare authorities in non European Union countries where Acomplia is available to determine how to implement an equivalent EMEA decision.