Business Wire

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

Share

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 88th Annual Congress of the European Atherosclerosis Society (EAS 2020).

Bempedoic acidreduced 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 acidwas 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 acidis 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.6,7,8

“Bempedoic acidprovides 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 88th 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.


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.

Contact information

Dr. Wolfgang Schiessl (Europe)
Daiichi Sankyo Europe GmbH
Director Product PR and Communications, Cardiovascular Europe
+49 151 1714 7317

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Saudi Arabia Sets out Strategy to Become a World Leader in Artificial Intelligence By 203021.10.2020 18:07:00 CESTPress release

Saudi Arabia revealed its National Strategy for Data & AI (NSDAI) which will make the country a global leader in Artificial Intelligence by 2030. Saudi Arabia’s NSDAI intends to put AI at the heart of the country’s development and growth. By 2030, Saudi Arabia’s vision is to become the place where the best of Data and AI is made reality. Under the strategy, Saudi Arabia will implement a multi-phase, multi-faceted plan that includes skills, policy and regulation, investment, research and innovation, and ecosystem development. This will enable the country to become a global hub for data and AI, and to rank among the top data-driven economies in the world. Speaking at the launch of the strategy, HE Dr. Abdullah Bin Sharaf Alghamdi, President of SDAIA, said: “The National Strategy for Data and AI sets the direction and foundations upon which we will unlock the potential of data and AI to fulfill our national transformation priorities and establish Saudi Arabia as a global hub for data and

Women 20 (W20) Challenges G20 Leaders to Close the Gap Between Imagination and Reality on Women’s Equality21.10.2020 18:01:00 CESTPress release

Women 20 (W20), the women’s engagement group to the G20, challenged G20 leaders to live up to their promises of the past and make women’s economic equality a reality. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201021005766/en/ W20 Chair Dr. Thoraya Al Obaid and G20 Chair of Trade and Investment His Excellency Dr. Majid Alqassabi with the final Communiqué of the W20 Working Group (Photo: AETOSWire) Laying out measures to expedite the economic recovery from the COVID-19 pandemic, the W20 presented its Communiqué to H.E. Dr. Majid Alqassabi, Minister of Commerce, Chair of G20 Trade and Investment, representing the Presidency of the G20. The pandemic provides an opportunity for G20 leaders to reset G20 economies based on the full and equitable participation of women. “Unless urgent action is taken, the pandemic will continue to exacerbate gender inequalities, expose vulnerabilities, and roll back gains made on women’s equali

Saudi Arabia Partners With the World Bank to Ensure No Nation Is Left Behind on AI21.10.2020 17:59:00 CESTPress release

The World Bank and Saudi Arabia have announced a long-term partnership to accelerate the use of Artificial Intelligence (AI) in developing nations in support of economic and development goals. The objective is to ensure that no nation is left behind in the race to unlock the value of AI while ensuring the appropriate safeguards are in place to manage the risks associated with AI. Under the partnership, the World Bank and Saudi Arabia, represented by the Saudi Data and Artificial Intelligence Authority (SDAIA), will cooperate to assist countries in creating policies and initiatives that harness the power of AI to support national development and growth. AI and related technologies are expected to unlock an additional $15tn of economic value worldwide before 2030, but many developing nations do not have yet the technical readiness to share in this new wealth. The partnership will support target nations to identify gaps in their own readiness and ability to utilize AI and data and develop

Taulia Appoints Andy Lee as Director, Supply Chain Finance21.10.2020 16:30:00 CESTPress release

Taulia, the leader in working capital technology solutions, has today announced the appointment of Andy Lee as Director, Supply Chain Finance. Based in New York, Lee will be responsible for expanding Taulia's funding partners, building strategic relationships and supporting product development in North America. “The natural next step for our growing team was to bring someone onboard with deep experience within the banking sector and superior knowledge of the fintech space. Andy will enable us to develop the right financial partnerships so that we can continue to offer a disruptive and valuable service to our customers,” says Alexander Mutter, Managing Director of Capital Markets, Taulia. “In these unprecedented times, supply chain finance has been a key source of working capital for businesses large and small. I’m looking forward to diving right in, driving strategic relationships and building connections with our North American partners that will help expand access to these solutions,

Eaton Launches New Metal 3D Printing Program to Reduce Development Time, Improve Efficiency21.10.2020 16:00:00 CESTPress release

Power management company Eaton today announced its Vehicle Group is implementing a new 3D metal printing program as a part of its Industry 4.0 strategy to reduce development time and improve efficiency. The first metal printer system was installed at the Kings Mountain, N.C., facility, and a global deployment of 3D polymer printing technology is slated to be completed by first-quarter 2021. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201021005571/en/ Eaton’s Vehicle Group reduced cost and development time using its 3D metal printing capabilities to produce this oil fill nozzle. (Photo: Business Wire) The 3D printers are being utilized to create high-quality fixtures, safety devices, automation grippers for assembly and handling, and maintenance components requiring replacement. Prototype development is following the same strategy to support faster product development trials and improve efficiency. Improving output and eff

Project Management Institute Launches Initial Products in Industry’s First Platform-Agnostic Suite of Resources to Accelerate Adoption of Citizen Development at Scale21.10.2020 15:00:00 CESTPress release

Project Management Institute (PMI), the world’s leading association for the project management profession, today launched the industry’s first, platform-agnostic educational resources for organizations seeking to implement and scale Citizen Development (CD) practices. The first two products in a planned suite of offerings are available now: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201021005531/en/ The PMI Citizen Development Body of Knowledge (CDBOK™) is a centralized resource that will help individuals and enterprises understand best practices for implementing citizen development within an organization at scale. The foundational training course is an e-learning training program that provides an introduction to citizen development and outlines best practices in CD methodologies. Citizen development platforms use intuitive “low-code” and “no-code” tools, so that even non-technical, non-specialist employees can create ap