Daiichi Sankyo Announces the Development of a Fixed-Triple Combination Lipid-Lowering Tablet to Address Persistent Gaps in the Management of Elevated LDL-C

Daiichi Sankyo Europe is pleased to announce the development of a fixed-triple oral combination lipid-lowering tablet of bempedoic acid, ezetimibe, and different doses of a statin, with the potential to lower low-density lipoprotein cholesterol (LDL-C) levels.^{i ii}

"As bempedoic acid and ezetimibe are already approved as a single-dose therapy, the development of an oral triple combination with different doses of a statin, will make it easier for physicians to tailor treatment to the individual needs of each patient", says Dr. Stefan Seyfried, Vice President, and Head Medical Affairs Specialty Medicines, Daiichi Sankyo Europe. "This approach exemplifies our dedication to our motto: 'we care for every heartbeat'

Daiichi Sankyo is prioritising the development programme further to ongoing data readouts from their funded MILOS and SANTORINI registries which continue to emphasise the persistent gaps in LDL-C management and the health inequalities this exacerbates.

Professor of Public Health and Honorary Cardiologist at Imperial College London, Professor Kausik Ray added, "Heart disease remains the leading cause of death in Europe despite the significant strides forward we have taken in recent years; improvements in part enabled by more effective cholesterol management. However, data from the MILOS and SANTORINI registries exposes the ongoing inconsistencies in LDL-C management, in particular the disparities with worse LDL-C control and lower uses of evidence based therapies in women. I welcome further research that continues to explore ways that we can close these gaps and improve outcomes."

Professor Raj Thakkar, President and CKD lead, Primary Care Cardiovascular Society, said, "The systematic and proactive population management of lipids is essential to reduce cardiovascular risk burden. To deliver this in an expedient, sustainable and efficient way is paramount. Ensuring all available therapies are used to minimise risk, including combination medicines, is key to delivering these goals

Notes to editors

The European Society of Cardiology (ESC) Congress takes place 29 August to 1 September 2025 in Madrid, Spain.

At ESC 2025 further clinical data from the SANTORINI and MILOS studies will be published, see about the trials below.

About SANTORINI

The SANTORINI study, funded by Daiichi Sankyo Europe, is a multinational, prospective, observational study that enrolled 9,602 patients with high and very high CV risk from over 623 sites in 14 countries across Europe. Patients were recruited between March 2020 and February 2021.^{iii iv} The primary objective was to document, in the real-world setting, the effectiveness of current LDL-C management approaches in high- and very high-cardiovascular-risk patients requiring lipid-lowering therapies over a 1-year period.^v

About MILOS

The MILOS study (NCT04579367), funded by Daiichi Sankyo Europe, is an ongoing, multinational, European observational study in adult patients diagnosed with primary hypercholesterolaemia or mixed dyslipidaemia. The aim is to evaluate the real-world use of bempedoic acid and bempedoic plus ezetimibe FDC.^vi

About Bempedoic Acid and its Fixed-Dose Combination with Ezetimibe

Concomitant use of bempedoic acid (NILEMDO)/bempedoic acid ezetimibe FDC (NUSTENDI) with simvastatin 40mg daily is contraindicated.

Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver. Bempedoic acid is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet:^vii

• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,^viii
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.^ix

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:

• in patients on a maximum tolerated dose of statin with or without ezetimibe or, ^x
• alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin in contraindicated.^xi

The bempedoic acid ezetimibe FDC is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet:^xii

• in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe,
• alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,
• in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.^xiii

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:²¹

• in patients on a maximum tolerated dose of statin and not adequately controlled with additional ezetimibe treatment or,
• in patients who are either statin-intolerant, or for whom a statin in contraindicated, and not adequately controlled with ezetimibe treatment or,
• in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.^xiv

Daiichi Sankyo Europe has licensed exclusive commercialisation rights to bempedoic acid and its FDC with ezetimibe in the European Economic Area, UK, Turkey and Switzerland from Esperion and is the full Marketing Authorisation Holder in these territories.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical need.

For more information, please visit www.daiichi-sankyo.co.uk.

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ⁱ Clinicaltrials.gov. NCT06686615. A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia (TRICONOS). Available from: https://clinicaltrials.gov/study/NCT06686615. Accessed August 2025.

ⁱⁱ Rubino J, et al. Combination of bempedoic acid, ezetimibe, and atorvastatin in patients with hypercholesterolemia: A randomized clinical trial. Atherosclerosis. 2021;320:122-8.

ⁱⁱⁱ Aguiar C, et al. Predictors of lipid-lowering therapy intensification over 1 year of prospective follow-up in Europe: insights from the SANTORINI study. Presented at European Society of Cardiology (ESC) Congress 2025.

^iv Ray KK, et al. Treatment gaps in the implementation of LDL cholesterol control among high- and very high-risk patients in Europe between 2020 and 2021: the multinational observational SANTORINI study. The Lancet Regional Health Europe 2023 Jun 1;29:100624.

^v ibid

^vi Clinicaltrials.gov. NCT04579367. Treatment with bempedoic acid and/?or its fixed-dose combination with ezetimibe in primary hypercholesterolemia or mixed dyslipidemia (MILOS). Available from: https://clinicaltrials.gov/study/NCT04579367. Accessed July 2025.

^vii MHRA. Nilemdo summary of product characteristics. Available at: https://products.mhra.gov.uk/product/?product=NILEMDO Accessed August 2025

^viii ibid

^ix ibid

^x ibid

^xi ibid

^xii MHRA. Nustendi -summary of product characteristics. Available at: https://products.mhra.gov.uk/product/?product=NUSTENDI Accessed August 2025

^xiii ibid

^xiv ibid

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Contacts:

James Hargrave
Director of Government Affairs
Daiichi Sankyo UK
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