NILEMDO® Delivers Significant Cholesterol Lowering in Addition to Statin Therapy Which is Maintained During 2.5 Years of Treatment

MUNICH, Germany–(BUSINESS WIRE)–Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced that NILEMDO^® (bempedoic acid) has demonstrated consistent tolerability and sustained efficacy over 2.5 years, in results presented at the ESC Congress 2020, the annual meeting of the European Society of Cardiology. Bempedoic acid is approved in Europe to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hypercholesterolaemia or mixed dyslipidaemia.¹ Up to 80% of patients do not reach guideline-recommended LDL-C goals despite receiving treatments such as statins and other lipid-lowering therapies (LLTs), and are at increased risk of a heart attack or stroke.^3,4,5

The data presented at ESC Congress 2020 comes from an open-label extension of the CLEAR Harmony trial, which originally showed that bempedoic acid is generally well tolerated and significantly reduces LDL-C compared to placebo at 12 weeks, on top of statins and other oral LLTs. This was maintained over the 52 weeks of the trial.⁶ People who completed CLEAR Harmony had the option to be enrolled into the open-label extension in which all participants received bempedoic acid for an additional 78 weeks, meaning some patients received treatment for 130 weeks in total. Findings from the extension study showed that bempedoic acid significantly lowered LDL-C by 14.4% on top of maximally tolerated statin therapy and other LLTs throughout 78 weeks of treatment, which are consistent with results seen in the original study.⁷

“Many people have a long-term need for treatments that are well tolerated and will help them keep their LDL-C levels low in order to reduce their risk of cardiovascular events, such as a heart attack or stroke. Therefore, it is important to know how people respond to treatment over longer-term time periods,” said Professor Kausik Ray, Professor of Public Health, Director of the Imperial Centre for CVD Prevention, Deputy Director of Imperial Clinical Trials Unit and Head of Commercial Trials Imperial College London and Consultant Cardiologist. “This study can give our colleagues confidence that the LDL-C reductions we see with bempedoic acid are maintained over time, without a significant increase of overall adverse events on top of statins and other LLTs.”

“Patients enrolled in CLEAR Harmony required additional LDL-C lowering, despite receiving maximum tolerated statin therapy and other oral LLTs. This is a group of people who are at high cardiovascular risk and have a significant need for combination therapies that can reduce cholesterol further,” said Dr. Michael Kerschnitzki, Medical Affairs Director, Antithrombotic & Cardiovascular at Daiichi Sankyo Europe. “Bempedoic acid and the bempedoic acid / ezetimibe fixed-dose combination tablet act in a complementary manner to existing LLTs and could become important additional treatments for patients to reach their LDL-C goals.”

This year’s ESC Congress 2020 is a virtual experience being held online due to travel restrictions. For more information please visit https://www.escardio.org/Congresses-&-Events/ESC-Congress.

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About NILEMDO^®

NILEMDO^® (bempedoic acid) is a new, first-in-class, oral treatment which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further.¹ Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver.¹

NILEMDO^® has been approved for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:¹

• 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.¹ Due to its unique mechanism of action, NILEMDO^® is not activated in skeletal muscle.¹

About NUSTENDI^®

NUSTENDI^® is a new oral treatment which combines two complementary ways of reducing cholesterol in a convenient once-daily tablet. NUSTENDI^® is a fixed dose combination tablet containing bempedoic acid (the active pharmaceutical ingredient in NILEMDO^®) and ezetimibe.⁸

NUSTENDI^® has been approved for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:⁸

• 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 a statin.

Daiichi Sankyo Europe has licensed exclusive commercialisation rights to NILEMDO^® and NUSTENDI^® 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 Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centred around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.

¹ European Medicines Agency. NILEMDO^® Summary of Product Characteristics. March 2020.
² Pinkosky SL, et al. Liver- specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nature Communications. 2016; 7:13457. DOI:10.1038/ncomms13457.
³ 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):111-188. doi:10.1093/eurheartj/ehz455.
⁴ 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.
⁵ 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.
⁶ Ray KK, et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med. 2019; 380:1022–32
⁷ Ballantyne CM, et al. Long-term safety and efficacy of bempedoic acid in patients at high risk of atherosclerotic cardiovascular disease: results from the clear harmony open-label extension. Poster presentation at the European Society of Cardiology Congress 2020.
⁸ European Medicines Agency. NUSTENDI^® Summary of Product Characteristics. March 2020.