Praluent approved to reduce CV risk in Europe

The European Commission has approved Sanofi and Regeneron’s Praluent for reducing cardiovascular risk in adults with established atherosclerotic CV disease (ASCVD), giving the drug another advantage in its battle against Amgen’s Repatha. The approval is based on results from the phase III ODYSSEY OUTCOMES trial, which assessed the effect of adding Praluent to maximally-tolerated statins in 18,924 patients who had an acute coronary syndrome (ACS) between 1-12 months (median 2.6 months) before enrolling in the trial. The trial met its primary endpoint, showing that Praluent significantly reduced the relative risk of major adverse CV events (MACE) by 15% in patients who had suffered a recent ACS. Additionally, Praluent was associated with a 15% lower risk of death from any cause, which occurred in 334 (3.5%) of patients in the Praluent group and 392 (4.1%) of patients in the placebo group.