DAIICHI-SANKYO-EUROPE
Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) announced today that the primary endpoint was met in the Phase 3 cardiovascular CLEAR (Cholesterol Lowering via Bempedoic acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes Trial, demonstrating statistically significant relative risk reduction in major adverse CV events (MACE-4) in patients treated with 180 mg/day bempedoic acid compared to placebo (with no or very low statin background).1,3
Comprehensive data from the CLEAR Outcomes Trial, led by US-based biotech company Esperion Therapeutics Inc., will be presented at a key medical congress in early 2023 and subsequently submitted to applicable regulatory authorities. The initial findings from the data indicate that bempedoic acid is the first oral, ACL inhibitor known to reduce both LDL-C levels and risk of major adverse CV events.1 The findings are congruent with previous significant evidence and the latest clinical guidelines highlighting that the lower a person’s LDL-C level, the lower their cardiovascular risk.4
“The positive results from the CLEAR Outcomes Trial represents a pivotal step towards reducing the impact of CVD in Europe for patients who are currently at high risk of heart attack and stroke,” said Professor Kausik Ray, Professor of Public Health and President of the European Atherosclerosis Society, Honorary Consultant Cardiologist, Director ICTU Global and Deputy Director of the Imperial Clinical Trials Unit at Imperial College London. “I am very excited to see more data from the trial over the coming months and better understand how bempedoic acid can continue to help clinicians bring LDL-C levels of patients to guideline-recommended goals and thus reduce the impact of cholesterol on CV health in Europe.”
“With 10,000 lives lost everyday to CVD in Europe, we are truly encouraged by this new data, which demonstrates that bempedoic acid does reduce the risk of serious CV events for patients who are at high-risk of experiencing a heart attack or stroke,”1,4 said Dr Stefan Seyfried, Vice President Medical Affairs Specialty Medicines, Daiichi Sankyo Europe GmbH. “We look forward to sharing additional analyses and insights, as well as working closely with the scientific and clinical communities, to better understand how the data can support their care for CVD patients across Europe.”
CLEAR Outcomes was a Phase 3, event-driven, randomised, multicenter, double-blind, placebo-controlled trial designed to evaluate whether treatment with bempedoic acid reduced the risk of CV events in patients with or who are at high risk for ASCVD with documented statin intolerance and elevated LDL-C levels (fasting blood LDL-C ≥ 100 mg/dL (2.6 mmol/L)).3 The study, which was fully enrolled in August 2019, included 14,014 patients at over 1,200 sites in 32 countries. Patients had at least 36 months of follow-up.3
-ENDS-
About bempedoic acid
Bempedoic acid (commercialised in the European Economic Area, Turkey and Switzerland as NILEMDO®▼) is a first-in-class, oral treatment which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further.2,5 Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver.2
Bempedoic acid has been approved for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2
- 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, which allows additional LDL-C lowering when added to statin or other lipid-lowering therapies. Due to its unique mechanism of action, bempedoic acid is not activated in skeletal muscle.
Daiichi Sankyo Europe has licensed exclusive commercialisation rights to bempedoic acid 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 is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realise our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.”
For more information, please visit www.daiichisankyo.com
▼ This medicinal product is subject to additional monitoring.
____________________________________________________
2 European Medicines Agency. NILEMDO Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf. Last accessed December 2022.
3 Nicholls, S.J., et.al. Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of bempedoic acid on cardiovascular events in patients with statin intolerance. Am Heart J. 2021. 235: 104–112.
4 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. Eur Heart J. 2020. 41(1):111–188.
5 SwissMedic. NILEMDO (bempedoic acid) Product Information for Human Medicinal Products. Available at: https://www.swissmedic.ch/swissmedic/en/home/about-us/publications/public-summary-swiss-par/public-summary-swiss-par-nilemdo.html. Last accessed December 2022.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221207005816/en/
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
H2SITE Secures EIC Accelerator Funding to Deploy a Flagship 1 TPD Ammonia Cracker Using Membrane Reactor Technology at a Port in North-West Europe3.7.2025 08:40:00 CEST | Press release
H2SITE has been awarded the EIC (European Innovation Council) Accelerator program for a project aimed at deploying a first-of-its-kind ammonia cracking unit capable of producing 1 ton of high-purity hydrogen per day. The system is based on H2SITE’s proprietary palladium-based membrane reactor technology, which enables the simultaneous catalytic decomposition of ammonia and selective hydrogen separation within a single unit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702142283/en/ Ammonia Cracker using Membrane Reactor Technology This breakthrough technology offers several compelling advantages over conventional ammonia cracking processes: Lowest Levelized Cost of Hydrogen (LCOH) from ammonia due to high efficiency and integrated operation Reduced energy consumption, operating at significantly lower temperatures (400–450 °C) than traditional cracking methods (typically 600–800 °C) High-purity hydrogen output, compliant
Curve Pay and Thales Join Forces to Securely Transform Digital Wallets on iPhone3.7.2025 08:00:00 CEST | Press release
This collaboration between Curve and Thales provides iOS users with greater control, flexibility, autonomy and digital-security for in-store contactless payments and digital wallets Curve, the ultimate digital wallet, today announced deepening its collaboration with Thales, the global leader in advanced technologies, delivering secure modern payment solutions for financial institutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702696837/en/ Thales D1 Platform to power CURVE PAY (Photo: Thales) This partnership comes on the back of Curve launching Curve Pay on iOS, marking a watershed moment in mobile payments. This partnership is a significant step to reshaping everyday spending, allowing Curve customers to benefit from NFC payment directly in the Curve App for contactless payments in store for all end-users on iOS and Android. Curve Pay is underpinned by Thales’ D1 platform on iOS and Android in Europe which allows
Medimaps Group Launches In Europe TBS Osteo Next-Generation Software For Advanced Bone Microarchitecture Assessment3.7.2025 08:00:00 CEST | Press release
New TBS Osteo Advanced next-generation software enhances fracture risk detection beyond standard of care in osteoporosis, a silent disease affecting over 32 million Europeans1 TBS Osteo Advanced next-generation software to be rolled-out across Europe Broad clinical adoption reinforces TBS Osteo leadership in bone microarchitecture evaluation for fracture risk assessment Subscription-based model offers ongoing services and access to future clinical innovations Medimaps Group S.A., a global leader in AI-driven bone microarchitecture imaging solutions, announces the European launch of its MDR-cleared next-generation TBS Osteo Advanced software. Following the product launch in the United States last month, this next milestone reflects the company's commitment to advancing osteoporosis detection and bone health management worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702082335/en/ Medimaps' TBS Osteo next-generatio
ISDA and Ant International Lead New Industry Report on Use of Tokenised Bank Liabilities for FX Settlement and Cross-Border Payments Under Project Guardian3.7.2025 08:00:00 CEST | Press release
Report builds on shared ledger technology and industry expertise of the co-leads as well as members of the Project Guardian FX workstreamIt includes proposed principles for leveraging tokenised bank liabilities and shared ledgers to drive industry adoption of tokenisation and enable 24/7, real-time FX settlement and lower costs for businesses globally The International Swaps and Derivatives Association (ISDA) and Ant International led the Project Guardian FX industry group to develop a new report for implementing tokenised bank liabilities and shared ledger in cross-border payments and foreign exchange (FX) settlement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702791535/en/ Report on Use of Tokenised Bank Liabilities for Transaction Banking by ISDA and Ant International, under the Monetary Authority of Singapore's (MAS) Project Guardian The joint report is produced under the Monetary Authority of Singapore's (MAS) Pr
Year-old European startup Maisa named alongside Google and Amazon in elite list of leading AI agent vendors in top global US research reports by Gartner3.7.2025 01:01:00 CEST | Press release
- First time a Spanish startup has made the list, thanks to its industry-first hallucination resistant ‘digital workers’ - AI startup is one of two European AI agent vendors in Gartner’s Hype Cycle report for Artificial Intelligence and Hype Cycle for the Future of Work lists Maisa, a rising star of enterprise AI, has been named by leading global research and advisory firm Gartner in its list of leading vendors for developing reliable AI agents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702640749/en/ Maisa founders David Villalón and Manuel Romero Inclusion in Gartner’s 2025 Hype Cycle for AI and Hype Cycle for the Future of Work marks the first time a Spanish startup has been mentioned in these influential reports. The company, which is barely a year old and made its first raise of $5m+ from leading US investors last year, now finds itself named alongside global giants Amazon Web Services, Google, Salesforce and Lan
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