Icosapent Ethyl

DUBLIN and BRIDGEWATER, N.J., April 08, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) (“Amarin”), a company committed to advancing the science of cardiovascular disease (CVD) worldwide, today highlighted the important scientific and educational activities featured at the American College of Cardiology (ACC) Scientific Sessions 2026 that emphasized elevated and high triglycerides (TG) as a contributor to residual cardiovascular (CV) risk and the role that icosapent ethyl (IPE) plays in contemporary lipid and cardiovascular risk management. Scientific dialogue across the sessions consistently reinforced that substantial residual CV risk can persist in many patients beyond low-density lipoprotein cholesterol (LDL-C) control, highlighting the importance of implementing the updated and newly issued 2026 ACC/American Heart Association (AHA)/Multi-society Dyslipidemia Guidelines. i These guidelines recognize that elevated TG levels contribute meaningfully to CV disease burden and ongoing CV events even in patients achieving LDL-C targets, underscoring the need for complementary therapeutic approaches beyond statin monotherapy to further reduce risk in high and very high-risk populations. Amarin-Supported Scientific Presentations Amarin-supported abstracts presented at ACC Scientific Sessions 2026 included a new secondary, post hoc analysis from REDUCE-IT® titled “Efficacy of Icosapent Ethyl Among Patients at Extreme Cardiovascular Risk: A Secondary Analysis of REDUCE-IT,” presented by Dr. Rahul Aggarwal. The analysis evaluated outcomes with icosapent ethyl on top of statin therapy among patients at the highest levels of CV risk and concluded that IPE compared to placebo significantly reduced CV events in both extreme and very high-risk patient populations. The abstract can be accessed here . In addition, a poster titled “Rates of Lipoprotein(a) Oxidation Increase at Elevated Levels in a Non-Linear Fashion and Are Inhibited by Eicosapentaenoic Acid (EPA),” presented by Dr. Samuel Sherratt, further explored biochemical pathways relevant to CV disease biology and EPA’s potential mechanistic effects. The abstract can be accessed here . Guideline and Late-Breaking Science Highlights Beyond Amarin-supported research, IPE was referenced during ACC guideline-focused programming in discussions addressing residual CV risk. These sessions emphasized that elevated triglycerides contribute meaningfully to CV event risk even among patients who have achieved LDL-C targets, underscoring the need for complementary and evidence-based therapeutic strategies beyond statin monotherapy. The newly released ACC/AHA/Multi-society Dyslipidemia Guidelines, along with other recent scientific statements, ii , iii also reiterated that fibrates are not recommended for routine use to reduce atherosclerotic cardiovascular disease (ASCVD) events due to inconsistent CV outcomes when added to statins. In a late-breaking clinical trials session, new data showed that substantial triglyceride lowering alone with an apoC3 inhibitor did not result in short‑term coronary plaque volume changes. Despite substantial reductions in triglycerides and remnant cholesterol, these changes were not consistently associated with reductions in coronary plaque volume, iv underscoring the complexity of residual CV risk and the need for outcomes and mechanistic evidence to assess long‑term clinical relevance. In prior published literature, IPE has demonstrated CV benefit in REDUCE‑IT v , with supportive mechanistic evidence from plaque imaging studies. EVAPORATE vi and CHERRY vii showed that treatment with IPE or eicosapentaenoic acid (EPA) was associated with favorable effects on coronary plaque characteristics over time. Together, these data suggest EPA‑based therapy may influence atherosclerotic disease biology beyond triglyceride lowering alone, helping to contextualize the potential mechanisms behind CV outcomes benefit observed with IPE on top of statin therapy. “The breadth of scientific discussion at ACC reflects a continued focus on residual cardiovascular risk and the importance of addressing lipid abnormalities beyond LDL‑C alone,” said Steven Ketchum, PhD, President of Research & Development and Chief Scientific Officer at Amarin. “Across guideline updates, original research presentations, late‑breaking science sessions, and medical education programs, the REDUCE‑IT cardiovascular outcomes trial evidence base and the role of icosapent ethyl continue to be represented in discussions relevant to contemporary cardiovascular care.” About Amarin Amarin is a global pharmaceutical company committed to reducing the cardiovascular disease (CVD) burden for patients and communities and to advancing the science of cardiovascular care around the world.  We own and support a global branded product approved by multiple regulatory authorities based on a track record of proven efficacy and safety and backed by robust clinical trial evidence. Our commercialization model includes a direct sales approach in the U.S. and an indirect distribution strategy internationally, through a syndicate of reputable and well-established partners with significant geographic expertise, covering close to 100 markets worldwide. Our success is driven by a dedicated, talented, and highly skilled team of experts passionate about the fight against the world’s leading cause of death, CVD.     About REDUCE-IT ® REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort). REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology. viii The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018. v The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019. ix Dr. Bhatt serves as the Chair of the REDUCE-IT Steering Committee with research funding paid to Brigham and Women’s Hospital and the Icahn School of Medicine at Mount Sinai. About Cardiovascular Risk Cardiovascular disease (CVD) is the number one cause of death in the world. In the United States alone, CVD - including heart disease, stroke, hypertension and heart failure - accounts for approximately 915,973 deaths per year, or about one death every 34 seconds. x Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%. xi Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins. xii , xiii , xiv About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules VASCEPA 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 was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA 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:  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 outlook for achievements in 2026 and beyond; Amarin’s 2026 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 annual report on Form 10-K for the fiscal year ended 2025. 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 ( ), the investor relations website ( ), including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. Amarin Contact Information Media Inquiries: Tegan Berry Amarin Corporation plc PR@amarincorp.com Investor Inquiries: Devin Sullivan & Conor Rodriguez The Equity Group on Behalf of Amarin devin.sullivan.ext@amarincorp.com or conor.rodriguez.ext@amarincorp.com Investor.relations@amarincorp.com ______________________ i Blumenthal RS, Morris PB, Gaudino M, et al. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2026 Mar 13:S0735-1097(25)10254-4. doi: 10.1016/j.jacc.2025.11.016. Epub ahead of print. ii American Diabetes Association Professional Practice Committee for Diabetes; Bajaj M, McCoy RG, Balapattabi K, Bannuru RR, Bellini NJ, Bennett AK, Beverly EA, Briggs Early K, ChallaSivaKanaka S, Das SR, Dixon DL, Echouffo-Tcheugui JB, Everett BM, Garg R, Laffel LM, Lal R, Matfin G, Pandya N, Pekas EJ, Peters AL, Pilla SJ, Romeo GR, Rosas SE, Segal AR, Szmuilowicz ED, ElSayed NA.10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026. Diabetes Care . 2026;49(Suppl 1):S216-S245. doi: 10.2337/dc26-S010 iii Conte E, Perone F, Cosyns B, et al. Therapies leading to coronary atherosclerosis plaque regression: A scientific statement of the European Association of Preventive Cardiology, the European Association of Cardiovascular Imaging of the ESC, the ESC Working Group on Atherosclerosis and Vascular Biology, and the ESC Working Group on Cardiovascular Pharmacotherapy—Part 2: Drugs’ specific effect on atherosclerosis. Eur J Prev Cardiol. 2025. doi: 10.1093/eurjpc/zwaf654 iv Marston NA, Bergmark BA, Prohaska TA, et al. Effect of APOC3 Inhibition with Olezarsen on Coronary Atherosclerosis: Essence-TIMI 73b Imaging Study. Circulation. 2026 Mar 30. doi: 10.1161/CIRCULATIONAHA.126.080012. Epub ahead of print. PMID: 41910513. v Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22. DOI: 10.1056/NEJMoa1812792 vi Budoff MJ, Bhatt DL, Kinninger A, Lakshmanan S, Muhlestein JB, Le VT, May HT, Shaikh K, Shekar C, Roy SK, Tayek J, Nelson JR. Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial. Eur Heart J . 2020;41:3925-3932. doi:10.1093/eurheartj/ehaa652 vii Watanabe T, Ando K, Daidoji H, et al.; CHERRY study investigators. A randomized controlled trial of eicosapentaenoic acid in patients with coronary heart disease on statins. J Cardiol. 2017 Dec;70(6):537-544. doi: 10.1016/j.jjcc.2017.07.007. viii Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148. DOI: 10.1002/clc.22692 ix Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802. DOI: 10.1016/j.jacc.2019.02.032 x Palaniappan LP, Allen NB, Almarzooq ZI, et al. 2026 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. 2026 Mar 3;153(9):e275-e906. doi: 10.1161/CIR.0000000000001412. Epub 2026 Jan 21. xi Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343. DOI: 10.1016/j.jacc.2018.04.061 xii Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145. DOI: 10.1016/j.amjcard.2016.04.004 xiii Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740. DOI: 10.1161/JAHA.118.008740 xiv Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease: New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.