Daiichi Sankyo Develops Triple Combination Lipid-Lowering Tablet to Address Persistent Gaps in LDL-C Management

Daiichi Sankyo Europe is developing a fixed-triple oral combination lipid-lowering tablet of bempedoic acid, ezetimibe, and different doses of a statin. This combination aims to address persistent gaps in LDL-C management, with the potential to tailor treatment to individual patient needs. The development program prioritizes ongoing data readouts from funded MILOS and SANTORINI registries, which emphasize the persistent gaps in LDL-C management and health inequalities.

Daiichi Sankyo Europe has announced the development of a fixed-triple oral combination lipid-lowering tablet comprising bempedoic acid, ezetimibe, and different doses of a statin. This innovative approach aims to address persistent gaps in the management of elevated low-density lipoprotein cholesterol (LDL-C) levels. The development program is prioritizing ongoing data readouts from the funded MILOS and SANTORINI registries, which highlight the ongoing challenges in LDL-C management and the exacerbation of health inequalities [1].

The fixed-triple combination tablet is designed to make it easier for physicians to tailor treatment to the individual needs of each patient. Dr. Stefan Seyfried, Vice President and Head Medical Affairs Specialty Medicines at Daiichi Sankyo Europe, stated, "As bempedoic acid and ezetimibe are already approved as single-dose therapies, 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. This approach exemplifies our dedication to our motto: ‘we care for every heartbeat’" [1].

The development of this combination therapy is aligned with the latest guidelines from the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Bempedoic acid has received a prestigious Level 1a recommendation in the 2025 ESC/EAS Guidelines for Dyslipidaemias management. This recommendation supports the strategic development of oral triple combination therapies by Esperion, which is Daiichi Sankyo's partner in this venture [2].

The MILOS and SANTORINI studies, funded by Daiichi Sankyo Europe, provide valuable insights into the real-world effectiveness of current LDL-C management approaches. The SANTORINI study enrolled 9,602 patients with high and very high cardiovascular risk, while the MILOS study focuses on evaluating the real-world use of bempedoic acid and bempedoic plus ezetimibe fixed-dose combinations (FDCs) in adult patients diagnosed with primary hypercholesterolemia or mixed dyslipidemia [1].

Professor Kausik Ray, a Professor of Public Health and Honorary Cardiologist at Imperial College London, welcomed the further research that continues to explore ways to close these gaps and improve outcomes. He emphasized that heart disease remains the leading cause of death in Europe despite the significant strides forward in recent years, and that improvements in part enabled by more effective cholesterol management [1].

The development of this fixed-triple combination tablet is a significant step towards improving the management of elevated LDL-C levels and reducing cardiovascular risk. As the market for lipid-lowering therapies continues to evolve, this innovation could significantly impact the way these medications are prescribed and used in clinical practice.

References:
[1] https://www.businesswire.com/news/home/20250830006011/en/Daiichi-Sankyo-Announces-the-Development-of-a-Fixed-Triple-Combination-Lipid-Lowering-Tablet-to-Address-Persistent-Gaps-in-the-Management-of-Elevated-LDL-C
[2] https://www.stocktitan.net/news/ESPR/esperion-s-bempedoic-acid-receives-level-1a-recommendation-in-bvm8r09jr393.html