New first-in-class cholesterol-lowering treatment NILEMDO® and its combination with ezetimibe NUSTENDI® approved in Europe

• NILEMDO® (bempedoic acid), a new, first-in-class, oral treatment and NUSTENDI® (bempedoic acid / ezetimibe) receive approval from the European Commission
•  ESC/EAS Guidelines recommend to intensively lower low-density lipoprotein cholesterol (LDL-C) to reduce cardiovascular risk, particularly in uncontrolled patients. However, 80% of patients do not reach guideline-recommended LDL-C goals, therefore additional treatment options are needed1,2,3
•  NILEMDO® and NUSTENDI® deliver significant LDL-C reductions as an add-on to current oral lipid-lowering therapies4,5

MUNICH, Germany, (April 6th, 2020) – Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced that the European Commission (EC) has approved both NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid / ezetimibe) for use in adults with primary hypercholesterolaemia or mixed dyslipidaemia in Europe.4,5 Bempedoic acid has a unique mechanism of action which is complementary to statins and other lipid-lowering therapies (LLTs) allowing additional LDL-C lowering on top of other LLTs compared to placebo.6 Both approvals were supported by data from the CLEAR trial programme conducted in more than 4,000 high- and very high-risk patients.6-10

“Across Europe, cardiovascular disease is one of the major causes of death killing more than four million people every year. High LDL-C is one of the major causes for heart attacks, strokes and other events that can lead to death,” said Professor Alberico L. Catapano, Chairperson of the guidelines Task Force and Professor of Pharmacology at the Department of Pharmacological and Biomolecular Sciences, University of Milan, Italy. “ESC/EAS Guidelines recommend intensively lowering LDL-C to reduce cardiovascular risk. The approval of bempedoic acid and its fixed dose combination with ezetimibe gives us important new treatment options that can be combined with other lipid-lowering treatments to help reduce LDL-C in people at risk of events like heart attacks and strokes.”