First-in-class cholesterol-lowering treatment NILEMDO®▼ and its combination with ezetimibe, NUSTENDI®▼, approved in Europe to lower LDL cholesterol and reduce cardiovascular risk
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NILEMDO®▼ (bempedoic acid), a first-in-class, oral treatment and NUSTENDI®▼ (bempedoic acid / ezetimibe
fixed-dose combination) receive label update approval from the
European Commission as treatments to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels 1,2 - This makes bempedoic acid the first and only LDL-C-lowering treatment indicated for primary and secondary prevention of cardiovascular events
- Up to 80% of patients do not reach guideline-recommended LDL-C goals despite receiving treatments such as statins and remain at an increased risk of a heart attack or stroke and in need of additional treatment3,4,5,6
In
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.8 Bempedoic acid / ezetimibe FDC combines two complementary ways of reducing cholesterol in a once-daily tablet, reduced LDL-C by 38% compared to placebo in high-risk patients already taking maximum-tolerated statin therapy.9
“Today's announcement marks a pivotal moment in our ongoing efforts to reduce cardiovascular risk. With the new indication, which covers both primary and secondary prevention, we can support healthcare professionals to better meet the treatment needs in their daily practice. At the same time, we’re confident it will reassure patients that their medication truly addresses their CV risk. This reaffirms our commitment to be a trusted ally in improving cardiovascular care throughout Europe,” said
“We are delighted with the European Commission’s approval, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide,” said
Today’s positive label update reaffirms the efficacy of both these treatments for reducing LDL-C levels and ultimately reducing patients’ risk of serious cardiovascular events,”
said Professor
EC approval is based on results of the Phase 3 CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes trial.10 The trial randomised a total of 13,970 patients aged 18–85 years old and was conducted at 1,250 sites in 32 countries, including 485 sites across
- a 13% reduction in the relative risk of major adverse cardiovascular events defined as a four-component composite of death from cardiovascular (CV) causes, non-fatal myocardial infarction, non-fatal stroke or coronary revascularisation (MACE-4).10
- Results of the key secondary endpoints and subgroup analyses have also been published.10
-ENDS-
About bempedoic acid and its fixed-dose combination with ezetimibe
Bempedoic acid is a first-in-class, oral, once-daily treatment to lower cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further.1,3 Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver.11
Bempedoic acid acts on the well-known cholesterol synthesis pathway, upstream of the statin target in the liver, which allows additional LDL-C lowering when added to statin or other LDL-C-lowering therapies.12 Bempedoic acid is not activated in skeletal muscle.11
Bempedoic acid is indicated in adults with established or at high risk for atherosclerotic CV disease to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:1
- in patients on a maximum tolerated dose of statin with or without ezetimibe or,1
- alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin in contraindicated.1
The fixed-dose combination NUSTENDI®▼ combines two complementary ways of reducing cholesterol in a once-daily tablet. NUSTENDI®▼ is a fixed-dose combination (FDC) tablet containing bempedoic acid (the active pharmaceutical ingredient in NILEMDO®) and ezetimibe.
Bempedoic acid / ezetimibe FDC is indicated in adults with established or at high risk for atherosclerotic CV disease to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:2
- in patients on a maximum tolerated dose of statin and not adequately controlled with additional ezetimibe treatment or,2
- in patients who are either statin-intolerant, or for whom a statin in contraindicated, and not adequately controlled with additional ezetimibe treatment or,2
- in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.2
About CLEAR Outcomes trial
The CLEAR Outcomes trial was a Phase 3, event-driven, randomised, multicentre, double-blind, placebo-controlled trial.13 It was designed to evaluate whether treatment with bempedoic acid, marketed as NILEMDO®▼ in
The trial, which was fully enrolled in
The primary endpoint of the CLEAR Outcomes trial was a four-component composite of major adverse CV events (MACE-4) defined as death from CV causes, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularisation.12 Key secondary endpoints included: MACE-3, a composite of three major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke); fatal and nonfatal myocardial infarction; coronary revascularisation; fatal and non-fatal stroke; cardiovascular death; and all-cause mortality.12
About
For more information, please visit www.daiichi-sankyo.eu
▼ This medicinal product is subject to additional monitoring.
References
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3 The Task Force for the management of dyslipidaemias of the |
4 Bandyopadhyay D., et al. Safety and efficacy of extremely low LDL-cholesterol levels and its prospects in hyperlipidemia management. |
5 Fox, K.M., et al. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clin Res Cardiol. 2018. 107;(5): 380–388. |
6 Kotseva, K., et al. Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: Results from the |
7 Timmis, A., et al. |
8 Ballantyne, C.M., et al. Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study. Atherosclerosis. 2018. 277: 195–203. |
9 Ballantyne, C.M., et al. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. 2019. 27;(6): 593–603. |
10 Nissen, S.E., et al. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med. 2023. 13;388;(15): 1353–1364. |
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13 Nicholls, S.J., et.al. Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of bempedoic acid on cardiovascular events in patients with statin intolerance. Am Heart J. 2021. 235: 104–112. |
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