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
Manna Air Delivery Raises $50Million Series B as It Announces Plans to Expand in the United States1.4.2026 18:00:00 CEST | Press release
ARK Invest, backer of OpenAI, Anthropic, Tesla and SpaceX, the Ireland Strategic Investment Fund and Schooner Capital back new round bringing total funding to $110M Plans to scale to 40 bases in the United States, supported by seven years of operational orchestration experience, and recently expanded its global partnerships with Uber, joining Deliveroo, Just Eat and DoorDash in delivering everyday items by air. Manna Air Delivery, a global leader in consumer drone delivery, has announced a $50 million funding round to scale its proven operations further in the United States and Europe. The round brings Manna’s total funding to $110million. Manna now operates one of the most active consumer drone delivery networks in the world, with more than 250,000 regulated commercial UAV flights completed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310714366/en/ Manna Air Delivery raises $50m Series B Investors in the round include
Bureau Veritas Launches an Independent AI Assessment Offering for European Enterprises, Developed in Partnership with Amazon Web Services (AWS)1.4.2026 17:45:00 CEST | Press release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), announces the launch of an AI systems audit to help European enterprises assess and demonstrate their compliance with the European Union's "AI Act" regulatory requirements. This offering combines on-site audits, document analysis, and direct testing to deliver an independent maturity report. Since the EU's AI regulation came into force in 2024, companies have faced major implementation challenges. According to a recent report*, 68% of them struggle to interpret the provisions of the text, while 60% have yet to put in place the governance needed to comply. Non-compliance can cost them up to 7% of annual revenue. Bureau Veritas has developed this new audit offering to help companies identify their compliance gaps and remedy them. Bureau Veritas's new audit offering comprises a pre-audit, document review, on-site audit, and direct testing, resulting in an independent report on the client's AI maturit
Greenland Resources Signs Eight Year Off-take Agreement With SSAB to Supply High Quality Molybdenum1.4.2026 16:29:00 CEST | Press release
Greenland Resources Inc. (TSX:MOLY, FSE:M0LY) (“Greenland Resources” or the “Company”) is pleased to announce the Company has signed a binding off-take agreement with SSAB, a Nordic and US-based steel producer headquartered in Sweden. The company is a leading producer on the global market for advanced high-strength steels providing solutions to the defence, automotive, infrastructure and energy industries. A stock exchange press release from SSAB can be found on their website at www.ssab.com This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260401270749/en/ The off-take agreement provides an established price floor and price ceiling and will allow SSAB to secure high quality low carbon emission ferromolybdenum extracted in Greenland and refined in Belgium. SSAB will be able to ensure a stable and responsibly sourced long term secured primary molybdenum supply with high sustainability standards and low scope 1&2 emissions from a
VDYNE Receives FDA Approval to Initiate the TRIVITA1 IDE Pivotal Trial of Transcatheter Tricuspid Valve Replacement System1.4.2026 15:30:00 CEST | Press release
VDYNE, Inc. (“VDYNE” or “the Company”), a privately held medical device company developing next generation transcatheter valve replacement technologies, today announced that the U.S. Food & Drug Administration (FDA) has approved an investigational device exemption (IDE) for the company’s pivotal clinical trial evaluating its Transcatheter Tricuspid Valve Replacement (TTVR) system. The IDE approval enables initiation of a U.S. pivotal study at leading clinical centers to evaluate the safety and effectiveness of the VDYNE system in patients with severe tricuspid regurgitation (TR). “This is a defining milestone for VDYNE and an important step toward bringing a much-needed therapy to patients with severe tricuspid regurgitation,” said Mike Buck, Chief Executive Officer. “Our focus now is on disciplined clinical execution and partnering with leading investigators to generate high-quality data that advances the field and improves patient care.” Significant unmet clinical needs exist in the
NetJets Introduces State-of-the-Art, Exclusive-Use Terminal in Augusta, Georgia1.4.2026 15:05:00 CEST | Press release
New facility set to elevate the experience for customers during golf’s most celebrated event—and beyond NetJets, the global leader in private aviation, is well underway on its development of a new exclusive-use terminal at Augusta Regional Airport (AGS). This state-of-the-art facility represents a significant investment in the region and reinforces NetJets’ commitment to delivering unparalleled experiences for its customers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330125414/en/ NetJets to open a new, exclusive-use terminal at Augusta Regional Airport (AGS). Guests arriving this April for golf’s most iconic championship will witness the construction in progress, including the finished ramp and foundational walls of what will soon become a full-service terminal. The private ramp, offering 432,000 square feet of space for aircraft parking, will be completed in time for the 2026 golf tournament. “Augusta is a key desti
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