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
bet365 Partners with TestMu AI to Accelerate Global Release Velocity with Agentic AI Quality Engineering31.3.2026 19:01:00 CEST | Press release
Streamlines Hillside Technology testing across browsers and mobile devices while supporting rapid expansion into regulated markets. TestMu AI (Formerly LambdaTest), the world's first full-stack Agentic AI Quality Engineering platform, today announced that Hillside Technology Limited, the technology powerhouse behind global online gambling leader bet365, has adopted its platform to unify software testing and support hundreds of weekly production releases. The global online gaming industry is currently experiencing a massive shift, with the market projected to exceed $150 billion by 2030. As mobile gaming becomes the primary touchpoint for users, the technical complexity of delivering a seamless, low-latency experience has grown exponentially. For industry giants like bet365, the need to validate software across an infinite matrix of hardware, screen resolutions, and OS versions is a mission-critical requirement. This partnership ensures that, as gaming becomes more mobile-centric, bet36
IFF Secures First Heart Health Claim for Soy Protein in Australia and New Zealand31.3.2026 16:00:00 CEST | Press release
Regulatory milestone opens heart health growth opportunities for food and beverage manufacturers IFF (NYSE: IFF), a global leader in flavors, fragrances, food ingredients and health & biosciences announced today that a new heart health claim for isolated soy protein has been accepted by the Food Standards Australia New Zealand (FSANZ). The approval enables food and beverage manufacturers in Australia and New Zealand to link soy protein consumption with healthy blood cholesterol levels. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330523416/en/ First heart health claim approved for soy protein in Australia and New Zealand. “For decades, IFF has invested in the science behind soy protein and its role in supporting cardiovascular health,” said Tony Andrew, vice president of protein solutions for IFF Food Ingredients. “This approved claim validates years of rigorous research and collaboration. With our deep expertise in ing
Sub-Q Bionics Closes $1.5M Pre-Seed Round to Advance Next-Generation Solution for Lymphedema Care31.3.2026 15:26:00 CEST | Press release
Sub-Q Bionics, a medical device company developing next-generation solutions to improve care for patients living with lymphedema, today announced the successful close of its $1.5 million pre-seed funding round. The round includes investment from Mayo Clinic and Yeda, the technology transfer company of the Weizmann Institute of Science, as well as several private investors. The Israel Innovation Authority also provided matching funds. The funding will enable Sub-Q Bionics to continue to develop its novel bionic lymph node technology designed to transform how lymphedema is managed, based on scientific innovations from the Weizmann Institute and Shamir Medical Center. The system aims to provide a solution to manage fluid with a subcutaneous implant that will allow patients freedom of movement, automatic fluid management and reduction of symptoms such as pain and swelling. Lymphedema affects millions of patients worldwide, especially breast cancer survivors, and remains significantly under
HTEC Achieves SOC 2 Type II Attestation, Reinforcing Commitment to Client Trust31.3.2026 15:25:00 CEST | Press release
HTECtoday announced that it has successfully achieved a SOC 2 Type II attestation, audited by Deloitte, demonstrating the company’s commitment to maintaining high standards in security, availability, and confidentiality. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260331132225/en/ HTEC today announced that it has successfully achieved a SOC 2 Type II attestation, audited by Deloitte, demonstrating the company’s commitment to maintaining high standards in security, availability, and confidentiality. For clients, this means working with a technology partner whose practices are standardized, consistently executed, and independently verified over time. It reflects a level of operational maturity where security, reliability, and data protection are built into every engagement. Achieving this standard required coordinated effort across the entire organization. Compliance, engineering, delivery, security, IT, legal, and people t
Impartner Redefines Partner Marketing Automation with Full Automation, AdTech and AI to Drive Measurable Revenue31.3.2026 15:00:00 CEST | Press release
New automation and AI capabilities connect partner campaigns and engagement directly to pipeline and revenue outcomes. Impartner, the world’s leading partner revenue orchestration platform, today announced a major advancement that unifies partner marketing automation within the platform, powered by full automation, AdTech and AI to turn partner marketing into measurable revenue. As partner ecosystems expand across regions, marketplaces and multi-tier models, marketing execution has often remained fragmented. Impartner eliminates those gaps by unifying recruitment, enablement, campaign automation and performance tracking within a single operational system, making partner demand generation and marketing fully operational, measurable, and scalable across all partner interactions. “What makes partner marketing successful is not content distribution, it’s execution, scale and measurable pipeline and revenue,” said Emile van de Klok, Senior Director of Channel Marketing Solutions at Impartne
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