Business Wire

Benefits of bempedoic acid in hypercholesterolaemia further demonstrated by data presented at the American College of Cardiology’s 69th Annual Scientific Sessions Together with World Congress of Cardiology (ACC.20/WCC)

Share

Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced results from two pooled analyses from four Phase 3 clinical trials for bempedoic acid and separate results from a Phase 2 study of the bempedoic acid / ezetimibe fixed dose combination (FDC). The data were presented at the American College of Cardiology’s 69th Scientific Sessions Together with World Congress of Cardiology virtual experience (ACC.20/WCC).

The 12-week Phase 2 bempedoic acid / ezetimibe FDC study (also known as Study 058) enrolled adult patients with type 2 diabetes mellitus (T2DM) at high risk of cardiovascular disease.6 The bempedoic acid / ezetimibe FDC reduced LDL-C by 40% compared to placebo with no increase in glycated haemoglobin (HbA1c), indicating that glycaemic control was not adversely affected.6 The bempedoic acid / ezetimibe FDC was well tolerated in Study 058, and the incidence of adverse events rates were generally comparable to placebo.6

The first pooled analysis of four Phase 3 clinical trials investigating bempedoic acid in adult patients with hypercholesterolaemia demonstrated that bempedoic acid resulted in a significant lowering of LDL-C, in addition to other lipid measurements (total cholesterol, non-high-density lipoprotein cholesterol (HDL-C) apoliopoprotein B, HDL-C), regardless of the presence of background ezetimibe.7 The use of bempedoic acid with or without background ezetimibe therapy, was in the same range for overall incidence of treatment emergent adverse events (TEAEs) in both study arms.7

The second pooled analysis showed that bempedoic acid lowers high sensitivity C-reactive protein (hsCRP), a key marker of inflammation associated with cardiovascular disease, by 42% at 12 weeks in patients with hypercholesterolaemia, regardless of the presence or intensity of background statin therapy.8

“We are encouraged by all the data presented today that continue to demonstrate the potential benefit of bempedoic acid for adult patients who need to reduce their LDL-C levels in order to reduce their risk of a cardiovascular event such as a heart attack or stroke,” said Wolfgang Zierhut, MD, Head of Antithrombotic and Cardiovascular Medical Affairs Department at Daiichi Sankyo Europe. “There is a need to reduce LDL-C levels as identified in the most recent ESC/EAS guidelines and the Phase 2 data presented today showing the potential to lower LDL-C for people at particularly high risk due to their diabetes without impacting glycaemic control is promising to see, however we will need validation from larger studies. Additional lipid-lowering treatments are badly needed to support patients, and we hope to be able to make bempedoic acid available in Europe soon.”

- ENDS -

About bempedoic acid

With a unique mechanism of action, bempedoic acid is being developed as a first-in-class, affordable, oral treatment which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further.1,2,3,4 Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver.1,2,3,4

Bempedoic acid has received a positive CHMP recommendation for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:1,2,3,4

  • 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.

Bempedoic acid acts on the well-known cholesterol synthesis pathway, upstream of the statin target in the liver, with a unique mechanism of action which allows additional LDL-C lowering when added to statin treatment.9 Due to its novel mechanism of action, bempedoic acid is not activated in skeletal muscle.9

About bempedoic acid / ezetimibe

Bempedoic acid / ezetimibe is being developed as an oral treatment which combines two complementary ways of reducing cholesterol in a convenient once-daily tablet.5 Bempedoic acid / ezetimibe is a fixed dose combination tablet.5

Bempedoic acid / ezetimibe has received a positive CHMP recommendation for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:5

  • 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 bempedoic acid and bempedoic acid / ezetimibe in the European Economic Area and Switzerland from Esperion. 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.


1 Laufs U, et al. Efficacy and Safety of Bempedoic Acid in Patients with Hypercholesterolemia and Statin Intolerance. J Am Heart Assoc. 2019;8(7):e011662.
2 Ray KK, et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med. 2019; 380:1022–32.
3 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. doi:10.1001/jama.2019.16585.
4 Ballantyne CM, et al. Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study. Atherosclerosis. 2018; 277:195–203.
5 Ballantyne, CM, et al. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. 2019; doi 10.1177/2047487319864671.
6 Bays, HE, et al. Bempedoic acid 180 mg + ezetimibe 10 mg fixed dose combination drug product vs ezetimibe alone or placebo in patients with type 2 diabetes and hypercholesterolemia. Poster presentation at American College of Cardiology’s 69th Scientific Sessions Together with World Congress of Cardiology virtual experience (ACC.20/WCC). March 2020.
7 Catapano, AL, et al. Bempedoic acid efficacy and safety in patients at high-risk for CVD treated with or without ezetimibe: pooled analysis of 4 phase 3 clinical trials. Poster presentation at American College of Cardiology’s 69th Scientific Sessions Together with World Congress of Cardiology virtual experience (ACC.20/WCC). March 2020.
8 Stroes, ESG, et al. Factors influencing bempedoic acid-mediated reductions in high sensitivity c-reative protein: analysis of pooled patient-level data from 4 phase 3 clinical trials. Poster presentation at American College of Cardiology’s 69th Scientific Sessions Together with World Congress of Cardiology virtual experience (ACC.20/WCC). March 2020.
9 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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Lydia Worms (Europe)
Daiichi Sankyo Europe GmbH
Communications & Product PR Europe
+49 (89) 7808751

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Blue Yonder Announces Binding Agreement To Acquire One Network Enterprises for Approximately $839 Million To Create Multi-Enterprise Supply Chain Ecosystem29.3.2024 15:13:00 EET | Press release

Blue Yonder, a leader in digital supply chain transformations, continues its forward momentum to revolutionize the supply chain and has today announced the signing of an agreement to acquire One Network Enterprises (One Network) for approximately $839 million, subject to adjustments. One Network, provider of the Digital Supply Chain Network™, is known for its autonomous and resilience services and is a leading global provider of intelligent control towers. Upon completion, Blue Yonder will be well positioned to serve customers’ needs across planning, execution, commerce, and networks. “Supply chains have become more complex, and as more and more companies reduce risk by diversifying sourcing of products globally, there is an increased demand for the sharing of information and resources across the whole value chain. This, along with increased disruptions and geopolitical risks, have put the pressure on organizations to build more resilient and robust supply chains,” said Duncan Angove,

Dubai Electricity and Water Authority PJSC Shareholders Approve Payment of AED 3.1 Billion in Dividends29.3.2024 15:12:00 EET | Press release

Dubai Electricity and Water Authority PJSC (ISIN: AED001801011) (Symbol: DEWA), the Emirate of Dubai’s exclusive electricity and water services provider and majority owner of the largest cooling services provider, which is listed on the Dubai Financial Market (DFM), reported that its shareholders have, in the general assembly held on March 28th, 2024, approved the payment of total dividend of AED 3.1 billion with a record date of April 8th, 2024. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240329162756/en/ Dubai Electricity and Water Authority PJSC shareholders approve payment of AED 3.1 billion in dividends (Photo: AETOSWire) General Assembly Details The meeting, chaired by HE Matar Humaid Al Tayer, Chairman of the Board of Directors of DEWA, was attended by HE Saeed Mohammed Al Tayer, MD & CEO of DEWA and Members of the Board of Directors of DEWA as well as 85.9% of the shareholders. The assembly was held on Thursday (2

PAN Finance Names Libertex ‘Global CFD Broker of the Year’29.3.2024 08:25:00 EET | Press release

As the first quarter of 2024 draws to a close, Libertex is thrilled to announce its first accolade of the new year! The established global financial publication PAN Finance has determined Libertex to be the ‘CFD Broker of the Year – Global 2024’ following a rigorous evaluation process conducted by the publication's highly experienced editorial and research teams. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328235325/en/ (Graphic: Libertex) PAN Finance is a trusted source of global financial intelligence with an impressively wide readership across 150 countries. Its ecosystem includes a quarterly magazine, special reports, a news website, and various social media channels. As an organisation, PAN Finance is committed to providing concise, intelligent, and up-to-date news for a worldwide readership of specialists spanning the entire finance industry. The company's awards programme aims to serve as a true indicator of exc

Midea Group releases its first-ever ESG brand story with an unexpected VIP visit highlighting its commitment to sustainability.29.3.2024 04:39:00 EET | Press release

Midea Group: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328526418/en/ Background: Midea Group, a leading global technology group, recently released its 2023 Environmental, Social, and Governance (ESG) Report with ambitious sustainable development goals set for 2030. They include achieving over 500 megawatts of photovoltaic power generation, reducing greenhouse gas emission intensity (scopes 1 and 2) by 0.040, secure Energy Management System Certification for 50 factories, and achieve 100% carbon footprint accounting for major categories of smart home appliances. This is aligned with the Sustainable Development Report Standards of the Global Report Standards of the Global Reporting Initiative (GRI). The new report and campaign focuses on four dimensions: Protect the Blue Planet, Build a Harmonious Community, Practice 'Bring Great Innovations to Life', and Jointly Create the Prosperous Ecology. The campaign: Midea’s ESG

DC Secretary Announces Annual Determinations Committees Outcome28.3.2024 23:14:00 EET | Press release

DC Administration Services, Inc. has today announced the composition of five regional Determinations Committees (DCs), effective from April 27, 2024. Voting Dealers (for all regions): Voting Non-Dealers (for all regions): Bank of America N.A. Citadel LLC Barclays Bank plc Elliott Management Corporation BNP Paribas Pacific Investment Management Company LLC Citibank, N.A. Deutsche Bank AG Goldman Sachs International JPMorgan Chase Bank, N.A. Voting Dealer for the Americas, EMEA, AEJ, and Japan Determination Committees: Mizuho Securities Co., Ltd. The process for selecting DC members is specified in the DC rules. The DC rules, along with more information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommittees.org/. View source version on businesswire.com: https://www.businesswire.com/news/home/20240328441002/en/ Contact information Press Inquiries: Orlando Figueroa orlando.figueroa@citadelspv.com

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
HiddenA line styled icon from Orion Icon Library.Eye