New Daiichi Sankyo Data Underscore the Effect of Bempedoic Acid in the Real-World Management of Dyslipidemia and Cardiovascular risk

Daiichi Sankyo (TSE:4568) today announced new results from the MILOS study that demonstrate the real-world impact of bempedoic acid administered either alone or as a fixed-dose combination with ezetimibe, in the management of dyslipidaemia. Presented at the European Society of Cardiology Congress 2026 in Munich, the findings show that the clinically relevant reductions in low-density lipoprotein cholesterol (LDL-C) achieved within the first year of treatment are estimated to translate into clinically meaningful reductions in 10-year cardiovascular (CV) risk.¹ The data further reinforce the clinical value of bempedoic acid, and its fixed-dose combination with ezetimibe, across a diverse range of patient subtypes, regardless of gender and glycaemic profile (diabetes, pre-diabetes, or normoglycemia).^2,3

Key findings from the new analyses of the MILOS study include:

• 10-year CV risk estimate reduction: An analysis of 960 at-risk patients estimated that one year of bempedoic acid-add-on therapy could translate into a 17.1% relative risk reduction and a 4.8% absolute risk reduction in the predicted risk of a major cardiovascular event over 10 years.¹
• Consistent efficacy across sexes: bempedoic acid, administered either alone or as a fixed-dose combination with ezetimibe, was highly effective in both women and men, delivering a 31% and 25% relative reduction in LDL-C, respectively.²
• Proven results regardless of glycaemic status: bempedoic acid-based treatment, with or without other lipid lowering therapies, delivered a mean relative reduction in LDL-C of at least 24.9% and increased the proportion of patients achieving their LDL-C goals within one year, regardless of their diabetes status.³

"The clinical relevance of this new data is clear. These results reinforce physicians’ confidence in using bempedoic acid and its combination with ezetimibe in real-world clinical practice, across a broad range of patient types, including in people with diabetes," says Prof. Klaus G Parhofer, Professor of Endocrinology and Metabolism, University of Munich, Germany. "The confirmation from real-world data, gives us confidence to use bempedoic acid, so that we can better manage our at-risk patients."

"At Daiichi Sankyo, our ongoing investment in cardiovascular research is driven by our desire to care for every heartbeat," said Dr. Stefan Seyfried, Vice President and Head of Medical Affairs, Specialty Medicines, Daiichi Sankyo Europe. "We are committed to supporting better outcomes in CVD, and our latest real-world results continue to demonstrate the impact of bempedoic acid alone or as a fixed-dose combination tablet with ezetimibe in CVD management across a broad range of patient types, so that no patient will be left behind."

These presentations at ESC Congress 2026 are a testament to the robust data generation program and continued investment of Daiichi Sankyo in cardiovascular health, providing physicians with the tools and insights needed to optimise patient management and address outstanding unmet needs.

Data Being Presented at ESC Congress 2026

MILOSstudy

Presentation title	Author	Session (Time, CET)
Predicted change in 10-year cardiovascular risk one year after initiation of bempedoic acid-based therapy in the MILOS study	KG. Parhofer	Moderated ePoster August 31 11:15-12:00
Real-world use of bempedoic acid in women and men: Pooled 1-year follow-up data from the observational, prospective, real-world MILOS study in Austria, Belgium, Germany, Italy, and the United Kingdom	I. Gouni-Berthold	Moderated ePoster August 29 17:15-18:00
Bempedoic Acid for LDL-Cholesterol Management in Patients with and without Diabetes: Insights from the MILOS Study	T. Stulnig	ePoster Rounds August 29 09:15-10:00

About MILOS

MILOS (NCT04579367) is an ongoing, multinational, European observational study in adult patients diagnosed with primary hypercholesterolaemia or mixed dyslipidaemia.⁴ The aim is to evaluate the real-world use of bempedoic acid and bempedoic plus ezetimibe fixed-dose combination. Beyond Germany, MILOS has sites in Austria, Belgium, Italy, the Netherlands, Spain, Switzerland and the UK.⁴

About Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit www.daiichisankyo.com.

References

1. Parhofer KG, et al. Predicted change in 10-year cardiovascular risk one year after initiation of bempedoic acid-based therapy in the MILOS study. Presented at the European Society of Cardiology (ESC) Congress 2026.
2. Gouni-Berthold I, et al. Real-world use of bempedoic acid in women and men: Pooled 1-year follow-up data from the observational, prospective, real-world MILOS study in Austria, Belgium, Germany, Italy, and the United Kingdom. Presented at the European Society of Cardiology (ESC) Congress 2026.
3. Stulnig T, et al. Bempedoic Acid for LDL-Cholesterol Management in Patients with and without Diabetes: Insights from the MILOS Study. Presented at the European Society of Cardiology (ESC) Congress 2026.
4. Treatment with bempedoic acid and/​or its fixed-dose combination with ezetimibe in primary hypercholesterolemia or mixed dyslipidemia (MILOS). Available at: https://clinicaltrials.gov/study/NCT04579367?viewType=Card&term=NCT04579367&rank=1. Last accessed July 2026.

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