DAIICHI-SANKYO-EUROPE
8.12.2022 08:01:35 CET | Business Wire | Press release
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
Netmore Named Smart Company of the Year at the Premios iAgua 20261.10.2026 19:00:00 CEST | Press release
Netmore recognized for commitment to Spanish water market backed by locally developed products, proven smart metering expertise, and deep local market knowledge Netmore Group, the leading network operator and platform provider for Massive IoT, today announced it has been named Empresa Smart del Año — Smart Company of the Year — at the Premios iAgua 2026, the awards of iAgua, the Spanish-speaking water sector's leading media platform. The award was presented at the closing gala of the Spain Smart Water Summit, held at the Meliá Avenida América in Madrid. The award recognises a company that has taken an unusual route into water. Netmore is not a technology firm that added connectivity to its portfolio: it is a network operator that decided to specialise in the water cycle. In eighteen months, it has completed four acquisitions and become the world's largest LoRaWAN® network operator, with more than eighteen million IoT devices under contract across more than fifty countries. Its commitme
Elliptic Sets the Engineering Bar for On-Chain Risk With “Built for Compliance” Paper as New Rules Take Hold and Banks Launch a Joint Stablecoin1.10.2026 15:40:00 CEST | Press release
Built for compliance arrives as crypto compliance rules tighten worldwide and a bank-led stablecoin enters the market Elliptic, the global leader in on-chain risk management, today published Built for compliance, a paper setting out the nine engineering decisions that determine whether an on-chain risk system can support fast, accurate and defensible compliance decisions at agentic scale. Machines are already moving money on their own, at machine speed. Compliance teams now have to make hundreds of thousands of decisions a day, at that same speed. However, many on-chain risk systems were never engineered to support that pace. A compliance system that computes exposure on a schedule delivers stale results. One that defines blockchain coverage loosely enough lets a screening miss exposure entirely. A system that skips testing disaster recovery, a spike or an outage, takes down the customer’s compliance system too. That gap between machine speed and system design is exactly what regulator
Impartner Releases AI Ecosystem Playbook to Help Organizations Move from AI Experimentation to Execution1.10.2026 15:00:00 CEST | Press release
The AI Ecosystem Playbook provides a practical framework for assessing AI readiness, identifying high-value opportunities, addressing foundational gaps, and building a roadmap for AI adoption. Impartner, the world’s leading partner revenue orchestration platform, today announced the release of its AI Ecosystem Playbook, a new resource designed to help leaders and teams assess their current AI capabilities, identify areas where AI can support business goals, and develop a practical path to implementation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261001661549/en/ Impartner’s AI Ecosystem Playbook helps organizations assess AI readiness and identify opportunities to apply AI across PRM 3.0, partner revenue orchestration, and the partner lifecycle. As AI moves from experimentation into everyday operations, companies need more than a collection of potential applications. They need a framework for understanding where they ar
Whiteford Adds Six Partners in New York City, Expanding its Litigation, International and Corporate Practices1.10.2026 15:00:00 CEST | Press release
Lateral group joins growing Midtown Manhattan office as firm pursues targeted expansion strategy Whiteford, Taylor & Preston, a full-service law firm with offices across the East Coast, today announced that six partners from Chambers-rated Lazare Potter Glazer & Moyle LLP have joined Whiteford’s New York office: David E. Potter, James F. Moyle, Johannes K. Gäbel, Jaipat Singh Jain, Anna Pia D. Felix and Jacob Englander. This team expands Whiteford's New York office to more than two dozen attorneys and deepens the firm's commercial and securities litigation, employment, cross-border and corporate capabilities in the New York market. The six partners bring decades of combined experience representing mid-market companies, investment advisers, hedge funds, foreign corporations, entrepreneurs and executives in litigation, regulatory investigations, and complex business transactions. "We are expanding with our clients, our markets and our reputation," said Martin Fletcher, Whiteford's Managi
Skechers Enters Super Shoe Era With Innovative Skechers AERO Elite1.10.2026 14:20:00 CEST | Press release
Groundbreaking Design Gives Elite Runners the Performance to Break Barriers and Records in Any Race Skechers is redefining what it means to run fast with the Skechers AERO Elite. The latest addition to the innovative Skechers AERO Series makes its global racing debut today—marking a landmark moment as the performance brand’s first super shoe. Engineered to perform from 5Ks to marathons, the design minimizes weight and maximizes responsiveness, all while delivering Skechers’ signature comfort. The AERO Elite is built to win with the performance runners at any level need to go further, faster, and achieve that next personal record. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261001865320/en/ Introducing the Skechers AERO Elite, the brand’s first super shoe designed for racing. “The Skechers AERO Elite is the culmination of years of elite-level running innovation—our most technically advanced running shoe to date and a direc
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