NILEMDO® significantly lowers cholesterol in people with familial hypercholesterolaemia shows new analysis presented at EAS 2020

• NILEMDO^® (bempedoic acid) is a new, first-in-class, oral, once-daily treatment which lowers cholesterol and can be combined with other treatments to help lower cholesterol even further¹
• Bempedoic acid 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, 2}
• Due to its unique mechanism of action, bempedoic acid is not activated in skeletal muscle which decreases the potential for muscle-related side effects^{1, 2}
• The new analysis demonstrates that bempedoic acid is effective in heterozygous familial hypercholesterolaemia, the most common kind of familial hypercholesterolaemia

MUNICH, Germany–(BUSINESS WIRE)–Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced that NILEMDO^® (bempedoic acid) has demonstrated significant cholesterol reductions in people with the most common form of inherited high cholesterol.^3,4 The data are from a pooled analysis of over 3,000 patients enrolled in two Phase 3 trials and were presented at the 88^th Annual Congress of the European Atherosclerosis Society (EAS 2020).

Bempedoic acid reduced low-density lipoprotein cholesterol (LDL-C) by 22.3% compared to placebo in people with heterozygous familial hypercholesterolaemia (HeFH) taking maximally tolerated statins with or without other lipid-lowering therapies (LLTs). Bempedoic acid was well tolerated, with no new safety signals seen.³ HeFH is a common condition affecting over 30 million people worldwide who have an increased risk of a cardiovascular event such as a heart attack.⁵

“Untreated HeFH increases the risk of atherosclerotic cardiovascular disease (ASCVD) 10-20-fold compared to people who do not have HeFH, primarily as a consequence of severe lifelong hypercholesterolaemia. Aggressive LDL-C lowering is the key intervention to prevent ASCVD events in patients with HeFH, but this is often difficult to achieve, so new LDL-C lowering therapies are needed,” said Professor P. Barton Duell, Professor of Medicine, Oregon Health & Science University, Portland, OR USA who presented the data at EAS 2020. “The results from data presented at EAS 2020 demonstrate that bempedoic acid provides clinically meaningful LDL-C lowering with a good safety profile when added to background LDL-C lowering medications in patients with HeFH. These results provide important new information for patients with HeFH and their healthcare providers, who now have an additional LDL-C lowering option to consider.”

Bempedoic acid is approved in Europe to reduce 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 LLTs, and are at increased risk of a heart attack or stroke. (Read more…)^6,7,8

“Bempedoic acid provides a new mechanism of action to lower LDL-C which is complementary to statins and other lipid-lowering therapies. This means it can be taken as an add-on to existing treatments to lower LDL-C levels even further,” said Jarkko Soronen, Medical Affairs Director, Antithrombotic & Cardiovascular at Daiichi Sankyo Europe. “High LDL levels are a proven, direct cause of ASCVD. Bempedoic acid, and its fixed-dose combination with ezetimibe, could become important new treatment options that have the potential to reduce the burden of cardiovascular disease in Europe, where associated direct healthcare costs amount to €111 billion per year.”

The 88^th EAS Congress was held as a virtual event due to travel restrictions. For more information please visit https://eas2020.com/.

– ENDS –

About NILEMDO^®

NILEMDO^® (bempedoic acid) is a new, first-in-class, oral, once-daily treatment which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further.¹ NILEMDO^® 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 which decreases the potential for muscle-related side effects.^1,2

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.⁹

NUSTENDI^® has been approved for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:⁹

• 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.

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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 Barton Duell P, et al. Efficacy and Safety of Bempedoic Acid in Patients with Heterozygous Familial Hypercholesterolemia: Analysis of Pooled Patient-level Data From Phase 3 Clinical Trials. Presentation at the European Atherosclerosis Society 88th Congress Virtual Meeting. October 2020.

⁴ Di Taranto, MD, et al. Familial hypercholesterolemia: A complex genetic disease with variable phenotypes. European Journal of Medical Genetics. 2020. 63;4:103831.

⁵ McGowan, MP, et al. Diagnosis and treatment of heterozygous familial hypercholesterolemia. Journal of the American Heart Association. 2019. 8;24:e013225.

⁶ 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. European Heart Journal. 2020 Jan 1;41(1):111-188. doi:10.1093/eurheartj/ehz455.

⁷ Fox KM, et al. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clinical Research in Cardiology 2018; 107: 380–388.

⁸ 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. European Journal of Preventative Cardiology. 2019;26(8):824–835.

⁹ European Medicines Agency. NUSTENDI^® Summary of Product Characteristics. March 2020.

Contacts

Dr. Wolfgang Schiessl (Europe)

Daiichi Sankyo Europe GmbH

Director Product PR and Communications, Cardiovascular Europe

+49 151 1714 7317