Two Single-Pill Triple Combination Lipid-Lowering Therapy Applications Validated in The European Union

EMA has validated two marketing authorization applications from Daiichi Sankyo in the EU for single-pill triple-combinations of established lipid-lowering agents: bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin If approved, the proposed therapies could be the first oral single-pill triple-combinations for lipid-lowering in the EU, aiming to simplify treatment for patients requiring multiple lipid-lowering agents The submissions reflect the commitment of Daiichi Sankyo to addressing unmet needs in cardiovascular disease

The European Medicines Agency (EMA) has validated two marketing authorization applications (MAA) from Daiichi Sankyo (TSE: 4568) for oral, single-pill triple-combination therapies. The applications seek approval for the treatment of adults with primary hypercholesterolemia or mixed dyslipidemia to reduce low-density lipoprotein cholesterol (LDL-C) levels and cardiovascular (CV) risk.

Despite the availability of effective therapies, treatment discontinuation remains a persistent challenge in lipid management.^1,2 Across both primary and secondary prevention, a significant number of patients at high and very high CV risk do not reach their guideline-recommended LDL-C goals, often due to the complexity and pill burden of taking multiple medications.² The applications cover two single-pill combinations of three established lipid-lowering agents: bempedoic acid with ezetimibe and atorvastatin, and bempedoic acid with ezetimibe and rosuvastatin.³ Multiple statin dose options of each of these statin combinations are intended to offer flexibility in tailoring treatment to individual patient needs. Much like the use of single-pill combinations in hypertension, this approach aims to support medication adherence, which is known to lead to better clinical outcomes.²

“The clinical relevance of the data supporting these single-pill triple-combination therapies is clear. It reinforces physicians’ confidence in the use of bempedoic acid and its combination with ezetimibe and a statin in real-world clinical practice, across a broad range of patient types, including in people with diabetes,”said Prof. Klaus G Parhofer, Professor of Endocrinology and Metabolism, University of Munich, Germany. “We often see patients who require treatment intensification to reach their cholesterol targets, but adding more pills can be a barrier to adherence. A single-pill combination of three therapies offers a simplified approach to treatment for these high-risk patients.”

“At Daiichi Sankyo, we are driven by our mission to care for every heartbeat, and these submissions represent another step in our commitment to cardiovascular health,” said Dr. Stefan Seyfried, Vice President and Head of Medical Affairs, Specialty Medicines, Europe, Daiichi Sankyo. “By combining three therapies into one, we aim to reduce the number of pills required as part of daily treatment.”

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. Ray KK, et al. The Lancet Reg Health. 2023;29:100624.
2. Weisser B, et al. Eur Heart J Cardiovasc Pharmacother. 2025;10(8):686–693.
3. Rubino J, et al. Atherosclerosis. 2021;320:122–128.

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