First-in-class cholesterol-lowering treatment NILEMDO®▼ (bempedoic acid) and NUSTENDI®▼ (bempedoic acid / Ezetimibe) approved in Europe

• NILEMDO^® (bempedoic acid), a first-in-class, oral cholesterol-lowering treatment and NUSTENDI^® (bempedoic acid / ezetimibe) receive approval from the European Commission
• ESC/EAS Guidelines recommend to intensively reduce low-density lipoprotein cholesterol (LDL-C) to lower cardiovascular risk, particularly in uncontrolled patients. However, at least 80% of patients at very high risk of cardiovascular events do not reach guideline recommended LDL-C goals, therefore additional treatment options are needed^1,2,3

·         NILEMDO^® (bempedoic acid) and NUSTENDI^®  (bempedoic acid / ezetimibe) deliver significant LDL-C reductions compared to placebo and are effective as an add-on to current oral lipid-lowering therapies4^,5

MUNICH, Germany, (April 06, 2020) – Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced that the European Commission (EC) has approved both bempedoic acid and bempedoic acid / ezetimibe fixed-dose combination for use in adults with primary hypercholesterolaemia or mixed dyslipidaemia in Europe.^4,5 Bempedoic acid has a novel mechanism of action which is complementary to statins and as an adjunct to diet alone or in combination with 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 3,600 patients requiring lipid-lowering therapy.^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.”

Bempedoic acid is a first-in-class, oral treatment which lowers cholesterol, and can be combined with other LLTs to help lower cholesterol even further. In a Phase III clinical study of statin-intolerant patients, it provided additional LDL-C lowering of up to 28% (placebo-corrected) on top of ezetimibe plus low-dose or no statin, compared to placebo by inhibiting ATP Citrate Lyase (ACL), an enzyme in the well-known cholesterol synthesis pathway, upstream of the statin target in the liver.^4,9

Bempedoic acid / ezetimibe is a fixed dose combination tablet which combines two complementary ways of reducing cholesterol in a once-daily, oral treatment with the potential to support adherence to treatment by reducing pill burden for patients. Bempedoic acid inhibits cholesterol production in the liver while ezetimibe reduces absorption of dietary cholesterol in the gut.^8,11 In a Phase III clinical trial it reduced LDL-C by 38% (placebo-corrected) compared to placebo in high cardiovascular disease risk patients already taking maximum-tolerated statin therapy.⁸

A combined safety analysis in more than 3,600 patients confirms that bempedoic acid was well tolerated, and overall adverse event rates were similar to placebo.[i] Due to its novel mechanism of action, bempedoic acid is not activated in skeletal muscle which decreases the potential for muscle-related adverse effects.^4,[ii]

Over 80% of patients at very high risk of cardiovascular events do not reach guideline-recommended LDL-C goals despite receiving treatments such as statins, and are at increased risk of a heart attack or stroke.^1,2,3

“Due to the limitations of existing lipid-lowering therapies, the need for additional add-on treatments remains to help people reach their LDL-C goals” said Benoit Creveau, Head of Cardiovascular Marketing at Daiichi Sankyo Europe. “Bempedoic acid and bempedoic acid / ezetimibe can be added to existing, oral lipid-lowering therapies and will help HCPs and their patients at high- and very high cardiovascular risk to take back control. The approval of bempedoic acid and bempedoic acid / ezetimibe in Europe is a key milestone for us at Daiichi Sankyo Europe and reflects our ongoing commitment to reducing the burden of hypercholesterolaemia.”

[i] Ballantyne, CM, et al. Safety profile of bempedoic acid: pooled analysis of 4 phase 3 clinical trials. Abstract: P5364.

[ii] Pinkosky SL, et al. Liver- specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nature Communications. 2016; 7:13457. DOI:10.1038/ncomms13457.