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
Menicon’s Largest Malaysia Plant Begins Commercial Production5.2.2026 10:00:00 CET | Press release
- Strengthening Global Production Capacity for the Rapidly Growing 1-Day Lens Market Menicon Co., Ltd. is pleased to announce that its new manufacturing facility in Kedah, Malaysia, has commenced commercial production. The plant strengthens Menicon’s long-standing commitment to technological excellence, uncompromising quality, and a stable global supply of contact lenses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260127294120/en/ The newly opened Malaysia plant is Menicon’s largest site to date and is dedicated exclusively to producing 1-DAY lenses. As global demand for 1-DAY lenses continues rising and the industry faces widespread supply constraints, Menicon has made significant capital investments to expand production capacity—even amid the uncertainties presented by the COVID-19 pandemic. Construction of phase 1, currently underway, will provide capacity for up to 500 million lenses per year. The construction plan i
Ryan Expands UK Business Rates and Property Tax Capabilities with Acquisition of WYM Rating5.2.2026 09:00:00 CET | Press release
Ryan, a leading global tax services and software provider, is pleased to announce the acquisition of Williams Young McKaig Ltd, a specialized commercial property consultancy, and its specialist rating division, WYM Rating, based in Edinburgh. The acquisition establishes Ryan’s property tax and business rates presence in Scotland and expands the Firm’s ability to serve clients with complex commercial property portfolios across the United Kingdom. Founded in 2012 by Richard Williams, Don Young, and Billy McKaig, WYM Rating is recognized for its client-centered approach and deep expertise across commercial property advisory. The consultancy supports landlords, occupiers, and investors through practical, market-informed advice grounded in decades of hands-on experience. WYM Rating’s capabilities span three focus areas, closely aligning with Ryan’s capabilities: Business rates and property tax Commercial property advisory Occupier and lease advisory “WYM Rating brings exactly the kind of sp
Fujirebio and Sysmex Begin Sales Collaboration for Dementia Testing5.2.2026 07:30:00 CET | Press release
Fujirebio Holdings, Inc. (HQ: Minato-ku, Tokyo; President & CEO: Goki Ishikawa; “Fujirebio”), a consolidated subsidiary of H.U. Group Holdings, Inc. (HQ: Minato-ku, Tokyo; Chairman, President and Group CEO: Shigekazu Takeuchi) and Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano, “Sysmex”) have agreed on a sales collaboration for dementia testing. This agreement follows continued discussions based on the Basic Agreement on Business Collaboration in the Field of Immunoassay concluded in October 2023.1 Sysmex will exclusively sell Fujirebio's fully automated Lumipulse® immunoassay systems and dementia-related reagents ("the Products") in regions and countries mutually agreed upon by both companies. Going forward, Fujirebio and Sysmex will collaborate to meet the growing testing needs accompanying the wider adoption of therapeutic drugs and will gradually expand the countries where the Products are sold. Since entering into the Basic Agreement on Business Collaboration in Octob
Invivoscribe® Launches LeukoStrat® KMT2A + MRD Assay to Advance High-Sensitivity Leukemia Testing in Clinical Trials and Patient Management Worldwide5.2.2026 06:30:00 CET | Press release
Invivoscribe, a leader in precision medicine and measurable residual disease (MRD) testing, today announced the addition of the LeukoStrat®KMT2A + MRD Assay and Software to its industry-leading oncology portfolio. The assay leverages digital PCR (dPCR) to support both screening and precise longitudinal MRD monitoring for KMT2A rearrangements in acute myeloid leukemia (AML) subjects. This quantitative test is currently available for research use in clinical trials and as a stand-alone kit for purchase by our global customers, and will soon be available as a service in our regional LabPMM® laboratories worldwide. The assay is available to detect key AML-associated KMT2A rearrangements, which account for the vast majority of KMT2A fusion partners in AML1 and those most commonly targeted in menin-inhibitor clinical development programs. Later this year, the assay will be enhanced with four additional KMT2A rearrangements which are frequently found in acute lymphocytic leukemia (ALL), expan
VeriSilicon Enhanced ISP8200-FS Series IP Achieves ASIL B Functional Safety Certification5.2.2026 01:00:00 CET | Press release
Enabling Next-Generation High-Performance Automotive Camera Systems VeriSilicon (688521.SH) today announced its latest enhanced versions of Image Signal Processing (ISP) IP ISP8200-FS series, ISP8200-ES and ISP8200L-ES, featuring improved performance and energy efficiency to better support complex automotive camera systems. These enhanced IPs have successfully achieved ISO 26262 ASIL B functional safety certifications issued by TÜV NORD, an international inspection and certification institution, further validating their suitability and reliability for ADAS and autonomous driving applications. The latest enhanced ISP8200-FS series IP can operate at up to 1.2 GHz and support data processing from up to 16 image sensors. It significantly improves the performance of multi-camera scheduling, enabling flexible data-access capabilities and efficient hardware pipeline utilization for automotive camera systems. The enhanced series IP integrates image processing technologies including Color Noise
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