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Sanofi: new indication for Praluent in Europe

(CercleFinance.com) - Sanofi announces that the European Commission has approved a new indication of its Praluent (alirocumab), to reduce the risk of cardiovascular events in patients with established cardiovascular disease.


This approval is based on the Odyssey Outcomes study, which showed that Praluent significantly reduced the relative risk of major cardiovascular events by 15% in patients who had recently suffered from acute coronary syndrome.

Data from this study of 18,924 patients, which was published in the New England Journal of Medicine last year, was also submitted to the US FDA, with a decision expected on 28 April.

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