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
QI Tech and Ant International’s Bettr Partner to Expand Credit Access for E-Commerce Merchants and Consumers in Brazil26.6.2026 06:26:00 CEST | Press release
The strategic partnership drives financial inclusion, launching working capital programs for SME and Buy Now, Pay Later (BNPL) options on e-commerce platforms QI Tech, a leading financial services infrastructure provider, has joined forces with Bettr, a leading provider of inclusive and embedded financial services under Ant International, to expand credit solutions for e-commerce sellers and shoppers. The strategic partnership aligns with Brazil’s ongoing efforts to promote inclusive finance, launching targeted lending programs directly within digital marketplaces. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260622444217/en/ Consumers can select BNPL option at checkout, facilitated by Bettr In its initial phase, QI Tech is collaborating with Bettr to provide working capital loans for small and medium-sized e-commerce businesses, allowing them to expand inventory and scale operations effectively. This partnership also incl
Andersen Global tilføjer Andersen in Indonesia25.6.2026 22:21:00 CEST | Pressemeddelelse
Andersen Global styrker sin tilstedeværelse i Sydøstasien, da VDB Loi in Indonesia skifter navn til Andersen in Indonesia og dermed bliver det nyeste medlemsfirma, der tilslutter sig organisationen. Andersen in Indonesia yder skattemæssig og juridisk rådgivning til multinationale selskaber og udenlandske investorer, der er aktive på det indonesiske marked. Firmaet kombinerer årtiers markedserfaring med en praktisk tilgang, der fokuserer på at levere præcis og individuel rådgivning om komplekse regulatoriske og internationale forhold. "At blive en del af Andersen-brandet afspejler vores engagement i at give kunderne praktisk skattemæssig og juridisk rådgivning af høj kvalitet på grundlag af et bredere internationalt samarbejde," udtalte Tommy Hendharto Oetomo, administrerende partner for Andersen in Indonesia. "Kunder, der driver virksomhed i Indonesien, har brug for stadig mere koordineret støtte på tværs af landegrænser. At blive et medlemsfirma styrker vores evne til at levere den se
I-Pulse Signs Definitive Agreement with the U.S. Department of Commerce for $250 Million CHIPS R&D Award25.6.2026 20:53:00 CEST | Press release
■I-Pulse Will Develop Cutting-Edge Semiconductors that Support American Reindustrialization and National Security Goals■I-Pulse’s Technology Enables Cost-Competitive Development of America’s Vast Untapped Geothermal Energy Resources I-Pulse Co-founders Robert Friedland, CEO, and Laurent Frescaline, CTO, announced today a definitive agreement with the U.S. Department of Commerce’s CHIPS Research and Development Office for a $250 million award for the further development of I-Pulse’s proprietary semiconductor and pulsed power technology. “With today’s announced investment, the Trump administration is strengthening America’s capabilities and enhancing its national and energy security goals,” said Secretary of Commerce, Howard Lutnick. Co-founder Robert Friedland said: “We are excited to partner with the U.S. government to advance our unique, American technology suite to benefit our great nation. This award supports the development of world-leading critical components in the pulsed power t
Burjeel Holdings Prices First MENA Healthcare Sukuk Since 2018, 3.2x Oversubscribed25.6.2026 19:31:00 CEST | Press release
Burjeel Holdings, a leading super-specialty healthcare group in the GCC listed on the Abu Dhabi Securities Exchange, priced its inaugural USD 500 million Regulation S 5-year senior unsecured Sukuk offering due 2031 under its newly established USD 1.5 billion Senior Unsecured Sukuk Programme. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260625449702/en/ Burjeel Holdings’ inaugural Sukuk was priced at a 7.000 % profit rate and a yield of 7.125% (Photo: AETOSWire) The offering attracted significant demand from high-quality international and regional investors, with the orderbook peaking at USD 1.6 billion, representing 3.2x oversubscription. The strength of the orderbook enabled Burjeel to tighten pricing from initial price thoughts in the mid-7% area, with the Sukuk priced at a 7.000% profit rate and a yield of 7.125%, representing the lowest 5-year yield by a GCC-based private non-investment grade corporate issuer since 202
Fossil Fuels Are a Thing of the Past; The Future Is Renewable: The Smarter E Europe Concludes With a Clear Message25.6.2026 19:03:00 CEST | Press release
Packed halls, a vibrant atmosphere and a buzzing vibe – after three days, The smarter E Europe 2026, Europe’s largest alliance of exhibitions for the energy industry, has come to a successful close. The event held at Messe München offered a glimpse of a future-oriented energy world powered by renewables. A strong signal with a clear message went out to the world from the Bavarian capital: The future is renewable. Renewable energies can help ensure a reliable, secure and cost-effective energy supply around the clock, seven days a week. A total of 2,650 exhibitors from 52 countries – many of whom had expanded their booth space compared with the previous year – demonstrated how this can work. More than 66 percent of exhibitors were from outside of Germany. They presented innovative and market-ready products ranging from virtual power plants, smart grid and load control, smart charging solutions, storage technologies and PV hybrid systems to digital platforms transparently and flexibly.The
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