DAIICHI-SANKYO

Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) announced today inaugural data from SANTORINI, the first European observational study since the 2019 ESC/EAS management of dyslipidaemia guidelines to assess the management of high- and very high-risk cardiovascular (CV) patients requiring lipid-lowering therapy (LLT), at the ESC Congress 2021, organised by the European Society of Cardiology. SANTORINI is a multinational, prospective, observational, non-interventional study, primarily designed to document, in routine clinical practice, the effectiveness of current treatment options for managing levels of LDL-C in these patients.^1,5

Results from the SANTORINI study, which has recruited 9,606 patients, show that at baseline, 18.6% of high- and very-high risk CV patients were not receiving any LLTs. The majority of patients (54.1%) received LLT as monotherapy, and combination LLT was only used in 27.3% of patients.¹ The 2019 ESC/EAS management of dyslipidaemia guidelines recommend that the lower the levels of LDL-C for high- and very-high risk CV patients, the more their cardiovascular risk is reduced.² Given that 80% of hypercholesterolaemia patients are not reaching guideline-recommended LDL-C goals, despite receiving LLTs, the SANTORINI findings reaffirm the need for more intensive use of LLTs.¹

“LDL-C is a major modifiable risk factor for the prevention of heart attacks, strokes and other cardiovascular events that can lead to death. The SANTORINI study demonstrates the unmet need and why it is vital to rethink approaches to manage cholesterol levels in high- and very-high risk CV patients, specifically ensuring that these patients receive the most appropriate lipid-lowering therapies, in accordance with best practice, to help them achieve their target LDL-C goals,” said Professor Kausik Ray, Professor of Public Health and President of the European Atherosclerosis Society, Honorary Consultant Cardiologist, Head of Commercial Trials and Deputy Director of the Imperial Clinical Trials Unit at Imperial College London, and Principal Investigator of SANTORINI, who added, “There is a clear need for additional treatment options that are well tolerated, help patients meet their LDL-C goals and thus improve clinical outcomes.”

Contextual background: Simulation study data presented at ACC 2021 and published in the JACC anticipate a significant 10-year CV risk reduction when combination therapies are utilised

Earlier this year (May 2021), simulation data pooled from four completed pivotal randomised, double-blind, placebo-controlled, Phase 3 studies of bempedoic acid,^6,7,8,9 were presented as a poster presentation at the American College of Cardiology’s (ACC) Scientific Session.¹⁰ The study which used the validated Second Manifestations of ARTerial disease (SMART) model, and has since been published in The Journal of the American College of Cardiology (JACC), predicted a reduction in CV risk in patients with atherosclerotic cardiovascular disease (ASCVD), if treated with bempedoic acid. The simulation study estimated that treatment with bempedoic acid on top of maximally tolerated statins would lead to a 3.3% absolute reduction in 10-year CV event risk compared with statins alone (p<0.0001).¹¹ In patients who are intolerant to statins, the simulation predicted a 6.0% absolute reduction in 10-year CV event risk with bempedoic acid compared to placebo (p<0.0001).¹¹ These results anticipate a significant risk reduction in CV events with bempedoic acid and reinforce the possible benefits of LDL-C lowering in high-risk patients with ASCVD.¹¹

“Cardiovascular disease causes the death of more than four million people in Europe every year, hugely impacting families and the healthcare community,” said Dr Garth Virgin, Executive Director Medical Affairs, Specialty Medicines, at Daiichi Sankyo Europe. “At Daiichi Sankyo, we continue to invest in studies that bring relevant scientific information to the medical community to help inform clinical decision-making. Our goal is to help reduce CV risk for high- and very-high risk patients and, ultimately, reduce the impact of cardiovascular disease for people and healthcare systems across Europe.”

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About SANTORINI:
The SANTORINI study is a multinational, prospective, observational study that, to date, has enrolled more than 9,500 patients from over 800 sites in 14 countries across Europe.⁵ The primary objective is to document, in the real-world setting, the effectiveness of current treatment modalities in managing plasma levels of LDL-C in high- and very high-risk patients requiring lipid-lowering therapies. The study population consists of high- and very high-risk patients previously diagnosed and treated as well as newly diagnosed and requiring treatment.

Only data from routine clinical practice will be documented and physicians will not be required to perform any mandatory assessment outside the routine clinical practice. To facilitate accurate recording of data, patients can optionally fill in a memory aid to note important details. Data collection is estimated to finish in Q4 of 2021 with a final report of the study results estimated for Q4 of 2022.

About bempedoic acid
Bempedoic acid (commercialised in the European Economic Area, Turkey and Switzerland as NILEMDO^® ▼ ) is a first-in-class, oral treatment which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further.¹² Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver.¹²

NILEMDO^® has been approved for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:¹²

• 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
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

NILEMDO^® 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 lipid-lowering therapies.¹² Due to its unique mechanism of action, NILEMDO^® is not activated in skeletal muscle.¹²

Daiichi Sankyo Europe has licensed exclusive commercialisation rights to NILEMDO^® in the European Economic Area, Turkey and Switzerland from Esperion and is the full Marketing Authorisation Holder in these territories.

About Daiichi Sankyo
Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.”

For more information, please visit www.daiichisankyo.com

References

▼ This medicinal product is subject to additional monitoring.

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¹ Ray KK, et al . Treatment of high- and very high-risk patients for the prevention of cardiovascular events in Europe: baseline demographics from the multinational observational SANTORINI study. Poster 80441. Presented at ESC Congress 2021, August 2021.

² The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). ESC/EAS guidelines for the management of dyslipidaemia. Eur Heart J. 2020 Jan 1;41(1):11 –188. doi:10.1093/eurheartj/ehz455.

³ Fox KM, 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: 380–388.

⁴ Kotseva K, et al. Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: Results from the European Society of Cardiology ESC-EORP EUROASPIRE V registry. Eur J Prev Cardio. 2019;26(8):824–835.

⁵ Ray KK, et al . Evaluation of contemporary treatment of high- and very high-risk patients for the prevention of cardiovascular events in Europe – Methodology and rationale for the multinational observational SANTORINI study, Atherosclerosis Plus , 2021, https://doi.org/10.1016/j.athplu.2021.08.003

⁶ Ray KK, et al . Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med . 2019; 380:1022–32

⁷ Goldberg AC, et al . Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease. The CLEAR Wisdom Randomized Clinical Trial. JAMA . 2019; 322(18):1780–1788

⁸ Ballantyne CM, et al . Banach, M. Mancini, G.B.J. et al . Efficacy and Safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study. Atherosclerosis . 2018 Oct; 277:195–203

⁹ Laufs U, et al . Banach, M. Mancini, G.B.J. et al . Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance. J Am Heart Assoc. 2019 Apr 2;8(7):e011662

¹⁰ Gunn L, et al. Estimated cardiovascular benefits of bempedoic acid in patients with established cardiovascular disease. 1056-13. Presented at ACC Congress 2021, August 2021.

¹¹ Ray KK, et al. Estimated cardiovascular benefits of bempedoic acid in patients with established cardiovascular disease. JACC. 2021; 77 (18, Supplement 1). https://doi.org/10.1016/S0735-1097(21)02818-7

¹² European Medicines Agency. NILEMDO^® Summary of Product Characteristics. March 2020.

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