DAIICHI-SANKYO-EUROPE
31.1.2020 13:02:10 CET | Business Wire | Press release
Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the marketing authorisations of both bempedoic acid and the bempedoic acid / ezetimibe fixed dose combination (FDC) tablet, recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C).
Bempedoic acid is being developed as a first-in-class, affordable, convenient, once-daily, oral therapy for people with hypercholesterolaemia who are unable to reach LDL-C goals after optimised oral lipid-lowering therapies and remain at high risk of a cardiovascular event, such as a heart attack or stroke.
The CHMP recommended granting bempedoic acid marketing authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- 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.
The CHMP recommended granting the bempedoic acid / ezetimibe FDC tablet marketing authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- 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.
“Cardiovascular disease is the leading cause of death in Europe, killing over four million people every year, and increased LDL-C levels are one of the most important risk factors. However, as many as 80% of people on statins are not reaching their LDL-C targets.7 This is not only disappointing for them but also challenging for their healthcare professionals,” said Benoit Creveau, Head of Cardiovascular Marketing at Daiichi Sankyo Europe. “The clinical development programme for bempedoic acid demonstrated consistent lowering of LDL-C in a broad range of patients, including those already receiving optimised oral lipid-lowering therapies. The CHMP opinion is an acknowledgement of these results and brings us one step closer to our commitment of helping patients in the European Union who have not yet achieved their LDL-C goals.”
The CHMP positive opinions are supported by a global pivotal Phase III clinical trial programme conducted in more than 4,000 patients. Bempedoic acid provided up to 18% placebo-corrected LDL-C lowering when used with moderate- and high-intensity statins and 21–28% placebo-corrected LDL-C lowering when used with low-dose or no background statin.3,4,5 The bempedoic acid / ezetimibe FDC tablet provided a 38% placebo-corrected LDL-C lowering when used with maximally-tolerated statin therapy, which may mean no statin at all.6
The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit. The European Commission will review the CHMP opinions and is expected to deliver its final decision in the first half of 2020. Bempedoic acid and the bempedoic acid / ezetimibe FDC tablet are also currently under regulatory review by the U.S. Food and Drug Administration (FDA) with PDUFA dates of February 21st and 26th 2020.
- ENDS -
Bempedoic Acid
With a targeted mechanism of action, bempedoic acid is an oral, once-daily ATP Citrate Lyase (ACL) inhibitor that reduces cholesterol synthesis in the liver and thereby lowers circulating LDL-C levels.3,5 It is intended for patients with hypercholesterolaemia and/or at high risk of atherosclerotic cardiovascular disease (ASCVD) who need additional LDL-C lowering despite maximally-tolerated statin therapy.
Bempedoic acid has a unique, innovative mode of action which is complementary to other lipid-lowering therapies, such as statins.4 Due to its liver-specific mode of action, bempedoic acid has a reduced potential to induce the muscle-related side effects commonly associated with statin therapy and provide additional LDL-C lowering on top of statin monotherapy in clinical trials. Bempedoic acid has been observed to reduce high‐sensitivity C‐reactive protein (hsCRP), a key marker of inflammation associated with cardiovascular disease.5
Daiichi Sankyo Europe has licensed exclusive commercialisation rights to these products in the European Economic Area and Switzerland from Esperion.
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 Nickolic D, et al . ETC-1002: A Future Option for Lipid Disorders? Atherosclerosis 2014 Dec;237(2):705–10.
2 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.
3 Ray KK, et al . Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med . 2019;380:1022–32.
4 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.
5 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.
6 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.
7 Fox KM, Tai M-H, Kostev K 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200131005239/en/
Link:
About Business Wire
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
Garvan Institute of Medical Research Joins Parse Biosciences’ Certified Service Provider Network15.7.2026 22:00:00 CEST | Press release
Researchers across Asia-Pacific gain a new option for high-quality single cell sequencing through Garvan's Evercode WT services Parse Biosciences, a QIAGEN company, and the leader in scalable and accessible single cell sequencing, today announced that the Genomics Platform Core Facility within the Garvan Institute of Medical Research has joined its Certified Service Provider (CSP) Program. The partnership broadens access to high-quality, scalable single cell sequencing across Australia, the wider Asia-Pacific region, and beyond. Garvan is one of Australia's preeminent medical research institutions, with the Genomics Platform having deep experience in cell sorting, capture, and sequencing. As a Certified Service Provider, Garvan will offer Parse's Evercode WT kits to researchers across the region. "We see a growing number of requests for Parse projects and find the technology easy to implement and run, generating great data," said Chris O'Keeffe, Cellular Genomics Lead at the Garvan Ins
Grafana Labs Named a Leader in 2026 Gartner® Magic Quadrant™ for Observability Platforms and Positioned Furthest in Completeness of Vision15.7.2026 20:21:00 CEST | Press release
Named a Leader for the third consecutive year and placed furthest in vision for the second year in a row, the company has had a landmark year of innovation as observability becomes essential infrastructure for teams building and running AI at scale. Grafana Labs, the company behind the open observability cloud, today announced it has been named a Leader in the Gartner® Magic Quadrant™ for Observability Platforms for the third consecutive year, and positioned furthest on the Completeness of Vision axis for the second year running. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715814984/en/ 2026 Gartner® Magic Quadrant™ for Observability Platforms We believe this placement reflects where the market is headed: toward open, composable observability that helps teams in the AI era understand systems that are increasingly complex and agentic, and rapidly scaling thanks to AI-assisted engineering. A Platform Built for the AI Era
Spectro Cloud Raises $100 Million Series D to Help Customers Move AI Infrastructure Into Production Across Enterprise, Public Sector, Neocloud and Sovereign Cloud Environments15.7.2026 18:20:00 CEST | Press release
Growth Equity at Goldman Sachs Alternatives leads oversubscribed round with strategic participation from AMD Ventures, Ericsson, LG Technology Ventures, and Maximus as organizations look to turn AI silicon into business outcomes Spectro Cloud, a leading provider of AI infrastructure management software, today announced it has raised more than $100 million in an oversubscribed Series D funding round led by Growth Equity at Goldman Sachs Alternatives, with strategic participation from AMD Ventures, Ericsson, LG Technology Ventures, and Maximus. The new funding brings Spectro Cloud’s total capital raised to $260 million and will accelerate the company’s mission to help enterprises, public sector organizations, neoclouds and sovereign clouds build and operate production AI infrastructure with greater control over cost, security and governance. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715551858/en/ Spectro Cloud raises $
K-Beauty Goes Global: Sales Surge 53% as Korean Innovation Reshapes Beauty Growth15.7.2026 16:00:00 CEST | Press release
New NIQ data shows K-Beauty value sales rose 53% year-over-year and 131% over two years, underscoring how regional beauty trends, social commerce and ingredient-led innovation are reshaping global beauty growth. NIQ (NYSE: NIQ), a global leader in consumer intelligence, today released new findings showing K-Beauty has become a rapidly growing global beauty segment, with value sales up 53% year-over-year and 131% over the past two years. The data points to a broader shift in beauty growth, as regional innovation, social commerce and digitally driven consumer demand increasingly shape what scales globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715867578/en/ K-Beauty accelerates across global markets In its latest report, K-Beauty Goes Global, NIQ shows how Korean beauty is reshaping consumer expectations, accelerating innovation cycles and redefining competitive dynamics across the global beauty market. What began
Viz.ai to Support the MINUTE Trial, a Landmark Multicenter Study Evaluating the SCUBA Technique for the Treatment of Intracerebral Hemorrhage15.7.2026 15:00:00 CEST | Press release
Viz Neuro™ Suite, including Viz ICH™ and Viz ICH Plus™, to facilitate rapid detection and care coordination for patients with basal ganglia hemorrhage across trial sites nationwide. Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced its support for the Minimally Invasive Neurosurgery Trial for Ultra-early Treatment (MINUTE) Trial, a prospective, multicenter, randomized study evaluating whether the SCUBA technique, an endoscopic, catheter-based approach for ultra-early evacuation of basal ganglia intracerebral hemorrhage (BGH), is a promising alternative to standard medical management to potentially improve functional patient outcomes. The study aims to initiate both randomization and surgical intervention within 120 minutes of key clinical time points, reflecting the urgent nature of intracerebral hemorrhage care. Participating sites will have the ability to leverage the Viz Neuro Suite platform, including Viz ICH and Viz ICH Plus, to
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