Business Wire

First-in-class cholesterol-lowering treatment NILEMDO ® ▼ (bempedoic acid) tablet and its combination with ezetimibe NUSTENDI ® ▼ (bempedoic acid and ezetimibe) tablet approved in Switzerland


Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics (NASDAQ: ESPR) announced today Swissmedic approval for NILEMDO®▼ (bempedoic acid) tablet and NUSTENDI®▼ (bempedoic acid and ezetimibe) tablet, offering new treatment options for people with high low-density lipoprotein cholesterol (LDL-C) in Switzerland.

This press release features multimedia. View the full release here:

Bempedoic acid is the first oral, once-daily treatment option approved in the last two decades for patients who have difficulty reaching their cholesterol-lowering goals. In a recent observational study, two-thirds of patients in Switzerland with very high cardiovascular risk did not achieve LDL-C target values set out by the European Society of Cardiology.3 Patients who do not reach their LDL-C lowering goals are at increased risk for heart attack and stroke.4 Diagnosis of high cholesterol has increased among older adults in Switzerland in the past 20 years.5

“Cardiovascular disease remains a leading cause of death in Switzerland. In 2017 it accounted for over 30% of deaths across the country, highlighting a critical need for new treatment options for the many people who are having difficulty reaching their LDL-C goals with existing lipid-lowering therapies,” said Dr. Lucas Schalch, Country Manager at Daiichi Sankyo Switzerland. “Today’s approval of NILEMDO® and NUSTENDI® is a pivotal milestone for patients in secondary prevention, offering them new, convenient treatment options and demonstrating another step forward in our commitment to reduce the risk of atherosclerotic cardiovascular disease.”

“Bempedoic acid is a first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers LDL-C by inhibiting cholesterol synthesis in the liver. This unique mechanism of action allows it to work alongside existing treatments,” said Ashley Hall, Chief Development Officer of Esperion. “Our focus is finding convenient, affordable ways for appropriate patients to manage LDL-C. That is why we also developed a single-tablet combination of bempedoic acid and ezetimibe, to help reduce pill burden.”

Bempedoic acid and its fixed combination drug product with ezetimibe were approved in the European Union and the United States earlier this year with different labels and indications.1,6,7,8 In Europe, the products are marketed as NILEMDO® and NUSTENDI®, and in the U.S. as NEXLETOL® and NEXLIZET® (respectively).1,6,7,8 The Esperion team discovered and developed bempedoic acid, drawing on its deep expertise in developing cholesterol-lowering medicines. With strong commercial capabilities, particularly in cardiovascular medicine, Daiichi Sankyo has licensed exclusive commercialization rights to bempedoic acid and the fixed combination drug product of bempedoic acid and ezetimibe in the European Economic Area, Turkey and Switzerland from Esperion. Marketing Authorization for both products in Switzerland will be transferred to Daiichi Sankyo.

Swissmedic approved bempedoic acid for the treatment of adults with clinically manifesting atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolaemia (HeFH) who need additional LDL-C lowering, as an adjunct to diet and in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies.9 The fixed combination drug product of bempedoic acid and ezetimibe is indicated as an adjunct to diet in adults with clinically manifesting ASCVD or HeFH for patients unable to reach LDL-C goals with the maximum tolerated dose of a statin combined with ezetimibe or bempedoic acid, or patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.10 Both approvals were supported by data from the CLEAR trial program, which included more than 3,600 high- and very-high-risk patients.9,10 The effect of bempedoic acid on cardiovascular morbidity and mortality is currently being investigated in 14,014 patients across 32 countries as part of the CLEAR Outcomes study.11

Bempedoic acid was generally well-tolerated in clinical studies. The most commonly reported adverse reactions with bempedoic acid during pivotal trials were hyperuricaemia, pain in extremity and anaemia. The majority of adverse reactions reported with bempedoic acid were mild to moderate in severity and balanced in occurrence with adverse events in patients receiving placebo.1,6-10

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:

Esperion Therapeutics

Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced Lipid Management Team at Esperion is committed to developing new LDL-C lowering medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. For more information, please visit and follow us on Twitter at

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Esperion’s commercialization plans for bempedoic acid tablet, its expectations for the market for medicines to lower LDL-C and the impact of bempedoic acid tablet in such market, including the commercial launch and the market adoption of bempedoic acid tablet in the United States and European Union. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ significantly from those projected, including, without limitation, delays or failures in Esperion’s clinical development and commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, the impact of COVID-19 on our business, clinical activities and commercial development plans, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.


▼ This medicinal product is subject to additional monitoring in the European Union

(1) European Medicines Agency. NILEMDO® Summary of Product Characteristics. 27 Nov 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) Rachamin Yael, et al. “Statin treatment and LDL target value achievement in Swiss general practice – a retrospective observational study,” 27 May 2020. Swiss Med Wkly. 2020;150:w20244:

(4) WHO. Cardiovascular diseases (CVDs) Factsheet. 2017. Available online at: Last accessed December 2020.

(5) Swiss Federation Federal Statistical Office report, Gesundheitsstatistik 2019, 29 Oct 2019:

(6) European Medicines Agency. NUSTENDI® Summary of Product Characteristics. 27 Nov 2020:

(7) U.S. Food and Drug Administration. NEXLETOL® Prescribing Information. 27 Nov 2020:

(8) U.S. Food and Drug Administration. NEXLIZET® Prescribing Information. 27 Nov 2020:

(9) Swissmedic. NILEMDO® (bempedoic acid) Product Information for Human Medicinal Products. December 2020.

(10) Swissmedic. NUSTENDI® (bempedoic acid and ezetimibe) Product Information for Human Medicinal Products. December 2020.

(11) Stephen J Nicholls et al. Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of Bempedoic acid on cardiovascular events in patients with statin intolerance. American Heart Journal (2020),

Contact information

Daiichi Sankyo Europe GmbH
Dr. Wolfgang Schiessl (Europe)
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 1982

(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

The Remittance Effect: Global Citizens Emerge as Economic First Responders of the Developing World27.1.2021 10:03:00 CETPress release

Person-to-person ("P2P") international transfers, or remittances, sent by global citizens to their homelands represent the largest foreign economic support structure for developing economies. According to a new report by Oxford Economics, commissioned by Western Union (NYSE: WU), a global leader in cross-border, cross-currency money movement, remittances have helped smooth COVID-19 pandemic-induced economic shocks, increasing the resilience of developing nations throughout 2020 and presenting a potential lifeline for recovery in 2021 and beyond. This press release features multimedia. View the full release here: The Remittance Effect: Global Citizens Emerge as Economic First Responders of the Developing World (Graphic: Business Wire) The Oxford Economics Report: The Remittance Effect: A Lifeline for Developing Economies Through the Pandemic and Into Recoveryidentifies several positive economic and remittance consumer fundamental

Temenos Extends Partnership with Schroders for Wealth Front Office27.1.2021 08:30:00 CETPress release

Temenos (SIX: TEMN), the banking software company, today announced that Schroders Wealth Management in Switzerland has selected Temenos Wealth Front Office to automate and enhance its advisory business. Schroders Wealth Management will deploy the state-of-the-art portfolio management system on its existing Temenos Transact core banking platform to provide intuitive and powerful capabilities for relationship managers, advisers and portfolio managers. Supported by Temenos, Schroders Wealth Management looks after £65.7 billion of assets for its clients worldwide, from offices in the UK, Channel Islands, Switzerland, Singapore and Hong Kong. With Temenos Wealth Front Office, Schroders Wealth Management benefits from standardized advisory processes. The solution includes dashboards for relationship managers and portfolio managers, client and investment profiling, investment proposal process, advanced order generation, comprehensive pre- and post-trade compliance checks, flexible benchmarkin

Data Gumbo Provides Real-Time OPEX Visibility; Supports Continuous Financial Management Across European Energy Sector27.1.2021 07:00:00 CETPress release

Data Gumbo, provider of GumboNet™ — the massively interconnected industrial smart contract network secured and powered by blockchain — today announced that it enables real-time operational expenses (OPEX) visibility for energy operators and service providers across Europe. By using field operating data to digitally confirm that commercial terms of existing contracts have been satisfied, smart contracts trigger automated payments between commercial counterparties to deliver real-time visibility into contract spend. “Energy operators and service providers are in need of information that can assist them in making difficult economic choices,” said Ove Sandve, Norway Country Manager at Data Gumbo. “GumboNet’s real-time OPEX capabilities unlock sustained digital visibility into financial health and management that can set up a company to tie field measurements to payments driving transactional certainty, improving cash flow, increasing value, and ultimately, attracting better investors.” Man

TransferWise and Visa Announce Global Partnership Following Successful Collaboration on Cloud Technology27.1.2021 06:01:00 CETPress release

Visa (NYSE: V) and TransferWise today announced a global partnership and the first use of Visa Cloud Connect, a new way for fintechs and partners to securely connect Visa’s global processing network, VisaNet, through the cloud. Visa Cloud Connect underpins a new global agreement between Visa and TransferWise that will enable the expansion of TransferWise’s multi-currency debit cards in Asia Pacific, Europe, Latin America and the Caribbean, the Middle East, U.K. and U.S. This press release features multimedia. View the full release here: The TransferWise multi-currency account allows consumers and businesses to hold and convert 55 currencies at the real exchange rate. The multi-currency debit card lets customers spend and withdraw directly from any of the currency balances. Expanding the offering into new markets would have previously required significant investment in local data centers, telecommunications infrastructure and spe

UserTesting Launches New Test Types and Interactive Visualization Capabilities to Bring Greater Customer Insight and Intuition to Businesses27.1.2021 03:00:00 CETPress release

Collecting fast customer feedback has become mission-critical when competing in what is a very new and different business world. The ability to empathize with customers and understand how their buying behaviors have changed has never been more important than it is today. UserTesting, a leading provider of on-demand human insight, today announced several new capabilities designed to help companies meet the ever-evolving needs of their customers, with more test types that can give a greater understanding of how they organize and prioritize information, and interpret experiences. This press release features multimedia. View the full release here: UserTesting January Product Release 2021 (Graphic: Business Wire) The January 2021 Product Release includes new test types for both web and mobile experiences, plus interactive visualization capabilities in the form of click maps, designed to reduce the amount of time it takes to review an

KPMG unveils Our Impact Plan ; shares progress against newly created Stakeholder Capitalism Metrics27.1.2021 01:01:00 CETPress release

KPMG today published its first global environmental, social and governance (ESG) plan. Our Impact Plan brings together new and existing ESG commitments under one umbrella, focusing on four important categories: Planet, People, Prosperity and Governance. The plan also catalogues current data across the global organization and reports against metrics outlined in a report created by the World Economic Forum (WEF) and drafted in consultation with its International Business Council (IBC), titled Measuring Stakeholder Capitalism, which KPMG had a key role in shaping. KPMG will continue to strengthen its commitments outlined in the plan and improve reporting on its progress in the months and years to come. KPMG Global Chairman and CEO, Bill Thomas said, “By harnessing our convening power, digital capabilities and expertise, KPMG has an opportunity and responsibility to help shape and lead on some of the critical issues the world faces—doing so is core to our purpose to Inspire Confidence and

PerkinElmer Launches Industry-First GPCR TR-FRET Binding Assay and Beta-Arrestin Kits to Help Advance Therapeutics Discovery26.1.2021 21:25:00 CETPress release

PerkinElmer, a global leader committed to innovating for a healthier world, today announced the addition of new assay kits to help further GPCR (G Protein-Coupled Receptor) therapeutic discovery. The new PerkinElmer offerings extend the company’s leading GPCR analysis portfolio, which includes innovative assays, plate readers, automation technologies and software solutions combined with siRNA, shRNA, CRISPR, and cDNA/ORFlibraries to help scientists more easily and accurately characterize receptors, screen compounds and streamline workflows. The new assays, which enable researchers to use the preferred cell models of their choice, include the HTRF GTP Gi binding kit, the industry’s first TR-FRET based assay for GTP binding; the B-arr2 recruitment kit; and HTRF total kits for B-Arrestin 1, B-Arrestin 2 and AP2. These assays will help scientists continue to better understand the important role GPCRs play in disease by studying the interaction, expression and potential modulation of intrac