First-In-Class Cholesterol-Lowering Treatment NILEMDO® (NEXLETOL® in the U.S.) and Its Combination with Ezetimibe, NUSTENDI® (NEXLIZET® in the U.S.), Approved In Europe To Treat Hypercholesterolemia and Significantly Reduce Cardiovascular Risk
ANN ARBOR, Mich. and MUNICH, Germany, May 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today that the European Commission (EC) has approved the label update of both NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. The EC’s decisions to update the labels of bempedoic acid and bempedoic acid / ezetimibe FDC are based on the positive CLEAR Outcomes trial results and makes them the first and only LDL-C lowering treatments indicated for primary and secondary prevention of cardiovascular events.
- Bempedoic acid is a first-in-class oral treatment which lowers cholesterol, and which can be combined with other treatments to help lower cholesterol even further.
- Bempedoic acid provided additional cholesterol lowering of up to 28% on top of statin therapy, compared to placebo.
- “Today's announcement marks a pivotal moment in our ongoing efforts to reduce cardiovascular risk.
- CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.