New Analyses from REDUCE-IT® and EPA Mechanistic Data to be Presented at the European Society of Cardiology (ESC) Congress 2025
DUBLIN and BRIDGEWATER, N.J., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced upcoming presentations at the European Society of Cardiology (ESC) Congress 2025, August 29th-September 1st, in Madrid, Spain, where new data will further illuminate the multifaceted cardioprotective effects of icosapent ethyl (IPE).
Data to be featured at ESC 2025 will provide deeper insight into the potential role of IPE in reducing cardiovascular (CV) risk through multiple mechanisms, including effects on inflammation, lipoprotein oxidation, CV risk associated with CV-kidney-metabolic (CKM) syndrome, and risk and duration of hospitalizations. Highlights include new analyses from the REDUCE-IT trial evaluating the clinical benefit of IPE, alongside mechanistic studies investigating the impact of eicosapentaenoic acid (EPA) on inflammasome activation, lipoprotein(a) [Lp(a)] oxidation, and pro-inflammatory protein expression in endothelial cells under conditions of oxidative stress.
"The data being featured at ESC continue to reinforce the clinical value of IPE in reducing cardiovascular risk across specific patient subtypes. These new REDUCE-IT post hoc analyses not only support the primary outcomes data but also provide important, hypothesis-generating insights into the impact of IPE on the risk and duration of hospitalizations, CV risk associated with CKM syndrome, and major adverse CV event (MACE) endpoint stratified by apolipoproteinB (ApoB) and triglyceride-rich lipoprotein-cholesterol (TRL-C) levels," said Steven Ketchum, Ph.D., EVP, President of R&D, and Chief Scientific Officer at Amarin. "Additionally, the mechanistic findings—including the effects of EPA on Lp(a) oxidation, pro-inflammatory protein expression in endothelial cells, and on modulating the activation of the NLRP3 inflammasome—advance our understanding of the underlying science of this molecule. Together, these results deepen the medical community's understanding of the role of IPE in cardiovascular care and its potential mechanisms of action."
Amarin's presentations will include both oral presentations and moderated poster presentations, reinforcing the company's commitment to advancing the science of cardiovascular care and addressing residual risk in patients worldwide. Amarin will also be supporting educational programing addressing residual cardiovascular risk by medical and scientific leaders in Europe.
Amarin Sponsored Symposium
- Addressing Residual Cardiovascular Risk: From Evidence To Experience
-August 29th, 15:15 CET
-Budapest - Hall 10
Featured Amarin-supported abstracts to be presented by international academic collaborators (italicized below) at ESC 2025 include:
Moderated Poster Presentations
- Icosapent Ethyl Reduces CVD Risk in Cardiovascular-Kidney-Metabolic Syndrome: REDUCE-IT CKM
Michael Miller, Deepak L. Bhatt, Eliot A. Brinton, Terry A. Jacobson, Ph. Gabriel Steg, Steven B. Ketchum, Armando Lira Pineda, Jean-Claude Tardif, Christie M. Ballantyne
- Available August 29th, 16:15 CET
-Station 10 – Research Gateway
- Icosapent Ethyl Reduces Cardiovascular Risk Across Apolipoprotein B and Fasting Triglyceride Rich Lipoprotein Levels
Waqas A. Malick, Deepak L. Bhatt, Ph. Gabriel Steg, Michael Miller, Eliot A. Brinton, Steven B. Ketchum, Armando Lira Pineda, Richard L. Dunbar, Jean-Claude Tardif, Fabrice M.A.C. Martens, Christie M. Ballantyne
- Available August 30th, 8:15 CET
- Station 12 – Research Gateway
- Eicosapentaenoic Acid (EPA) Inhibited Lipoprotein(a) [Lp(a)] Oxidation and its Effects on Expression of Oxidative Stress and Pro-Inflammatory Proteins in Endothelial Cells
Samuel C.R. Sherratt, Peter Libby, Richard L. Dunbar, Deepak L Bhatt, R. Preston Mason
- Available August 29th, 13:15 CET
- Station 11 – Research Gateway
Oral Presentations
- Effects of Icosapent Ethyl on Risk and Duration of Hospitalizations and Death in REDUCE-IT
Michael Szarek, Deepak L. Bhatt, Michael Miller, Eliot A. Brinton, Jean-Claude Tardif, Christie M. Ballantyne, Steven B. Ketchum, Mandeep R. Mehra, Ph. Gabriel Steg
- Available August 30th, 8:15 CET
- Sofia (North Convention Centre)
- Eicosapentaenoic Acid (EPA) Modulates Inflammasome Activation in Monocyte-derived Macrophages Isolated from Individuals with and Without Established Atherosclerotic Cardiovascular Disease (ASCVD)
Joanna K Ward, Usman Shah, Paul E Squires, Kelvin Lee, Claire E Hills
- Available August 31st, 14:30 CET
- Science Box 2 – Research Gateway
About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.
About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug's initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than twenty-five million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Denmark and Austria.
United States
Indications and Limitation of Use
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
- VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
- It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
- VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin.
- Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
- Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.
FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Europe
For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please visit: https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf
Globally, prescribing information varies; refer to the individual country product label for complete information.
Forward-Looking Statements
This press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin's key achievements in 2024 and the potential impact and outlook for achievements in 2025 and beyond; Amarin's 2025 financial outlook and cash position; Amarin's overall efforts to expand access and reimbursement to VAZKEPA across global markets; expectations regarding potential strategic collaboration and licensing agreements with third parties, including our ability to attract additional collaborators, as well as our plans and strategies for entering into potential strategic collaboration and licensing agreements and the overall potential and future success of VASCEPA/VAZKEPA and Amarin that are based on the beliefs and assumptions and information currently available to Amarin. All statements other than statements of historical fact contained in this press release are forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including Amarin's quarterly report on Form 10-Q for the period ending June 30, 2025 and annual report on Form 10-K for the fiscal year ended 2024. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin's forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (www.amarincorp.com/investor-relations) including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts
Availability of Other Information About Amarin
Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (investors.amarincorp.com), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin's investor relations website and may include social media channels. The contents of Amarin's website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Amarin Contact Information
Investor & Media Inquiries:
Mark Marmur
Amarin Corporation plc
[email protected]
[email protected]
