Amarin Highlights Guideline Recommended Role of Icosapent Ethyl in Managing Cardiovascular Risk Following Release of Updated 2026 ACC/AHA/Multisociety Dyslipidemia Guideline

DUBLIN and BRIDGEWATER, N.J., March 18, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) (“Amarin”), a company committed to advancing the science of cardiovascular disease (CVD) worldwide, applauded the recommendation that the treatment of CV risk in patients with hypertriglyceridemia be part of a broader dyslipidemia management as discussed in the 2026 American College of Cardiology (ACC) / American Heart Association (AHA)/Multisociety Dyslipidemia Guideline Update.ⁱ 

These newly-issued, evidenced-based recommendations summarize the clinical role of icosapent ethyl (IPE) in reducing cardiovascular (CV) risk in statin-treated patients with elevated triglycerides (TG) and fully align with Amarin’s commitment to addressing the burden of CV disease across the healthcare ecosystem.ⁱⁱ 

Patients at high CV risk frequently fail to achieve LDL‑C targets, and few receive evidence‑based adjunct therapies.^iii,iv This updated dyslipidemia guideline reflects a shift in CV care, toward lifelong, prevention-first management, encouraging earlier screening and a broader approach to risk reduction beyond low-density lipoprotein (LDL-C) alone to address drivers of residual or persistent CV risk. Importantly, the guideline recognizes that achieving LDL-C targets does not eliminate cardiovascular risk, and that many patients continue to experience CV events despite optimized statin therapy.

The updated guideline reinforces that patients on statin therapy can experience residual CV risk driven by elevated TG levels - a significant clinical challenge affecting millions of Americans. According to the guideline, elevated TG levels contribute meaningfully to CV disease burden and ongoing cardiovascular events even in patients achieving LDL cholesterol targets, underscoring the need for complementary therapeutic approaches beyond statin monotherapy.

Amarin’s VASCEPA^®/VAZKEPA^® (icosapent ethyl) is an effective, safe, oral therapy that has been prescribed more than 30 million times globally. It is the first and only FDA-approved oral therapy proven to reduce the risk of CV events (such as a heart attack or stroke) by 25% when added on top of recommended statin therapy in high-risk patients with elevated and high TG levels.

Importantly, the guideline distinguishes therapies aimed at pancreatitis prevention from those proven to reduce atherosclerotic cardiovascular disease (ASCVD) events, reinforcing that CV outcomes - not biomarker changes alone - must guide treatment decisions. For patients who remain at elevated CV risk despite optimized statin therapy, the guideline supports the addition of evidence-based therapies specifically proven to reduce cardiovascular events, such as icosapent ethyl (IPE). This position is consistent with guidance from other cardiovascular societies, including the 2025 ESC/EAS Dyslipidemias guideline focused update which states that “high-dose icosapent ethyl (as in the REDUCE-IT trial) should be considered for high-risk or very high-risk patients with elevated triglyceride levels (fasting triglyceride level 135–499 mg/dL [1.52–5.63 mmol/L]) despite statin therapy to lower CVD events.” Together, these guideline updates reflect growing global consensus around the importance of addressing residual cardiovascular risk beyond LDL-C lowering alone.

"This guideline update is a meaningful step forward for patient care," said Michael Miller, MD, MASPC, FACC, FAHA, FNLA, Cardiologist and Professor of Medicine, Hospital of the University of Pennsylvania. "We now have clear evidence-based guidance distinguishing which triglyceride-lowering therapies truly reduce cardiovascular outcomes. Icosapent ethyl stands out as the only TG-lowering medication that reduces ASCVD event risk in combination with statin therapy in individuals at high risk of ASCVD with moderate TG elevations who continue to face cardiovascular events despite achieving sufficient LDL-C lowering. As clinicians, we have an opportunity - and responsibility - to utilize this updated guidance to better protect our high-risk patients from additional cardiovascular events."

The 2026 Dyslipidemia Guideline also specifically addresses the limitations of certain triglyceride-lowering agents when added to statin therapy, noting again that fenofibrates do not reduce cardiovascular risk when added to statin therapy. In contrast, icosapent ethyl has consistently demonstrated robust CV event reduction when added to statin treatment in high-risk patients with elevated TGs, as shown in the landmark cardiovascular outcomes trial, REDUCE-IT. 

“Taken together, these recommendations reinforce the importance of targeting residual cardiovascular risk with therapies proven to improve outcomes,” said Deepak L. Bhatt, MD, MPH, MBA, Director of the Mount Sinai Fuster Heart Hospital at the Icahn School of Medicine at Mount Sinai in New York and Principal Investigator of REDUCE-IT. “For appropriate statin-treated patients with elevated TGs, icosapent ethyl offers a well-established, evidence-based option to meaningfully reduce cardiovascular events.”

"The 2026 ACC/AHA/Multisociety guidance marks an important evolution in cardiovascular prevention," said Aaron Berg, President & Chief Executive Officer of Amarin. "The updated recommendations provide further validation that icosapent ethyl addresses an important medical need for the millions of patients with persistent cardiovascular risk. This guideline strengthens our commitment to providing physicians and patients with evidence-based options to reduce cardiovascular events and improve patient outcomes. Beyond clinical outcomes, the emphasis on reducing residual CV risk carries important health economic implications. CV events remain a leading driver of healthcare utilization and cost, and therapies proven to reduce events - not just lipid levels - have the potential to improve long-term outcomes while reducing hospitalizations, procedures, and overall healthcare burden." ^v,vi

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.^vii The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.ⁱⁱ The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.^viii These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com. 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.^ix

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%.^x 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.^xi,xii,xiii

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: 
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 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 (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. 

Amarin Contact Information 
Media Inquiries: 
Tegan Berry 
Amarin Corporation plc 
[email protected]

Investor Inquiries: 
Devin Sullivan & Conor Rodriguez 
The Equity Group on Behalf of Amarin
[email protected] or [email protected]
[email protected]

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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 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.
ⁱⁱⁱ Navar AM, Kolkailah AA, Gupta A, et al. Gaps in Guideline-Based Lipid-Lowering Therapy for Secondary Prevention in the United States: A Retrospective Cohort Study of 322,153 Patients. Circ Cardiovasc Qual Outcomes. 2023;16(8):533-543. doi: 10.1161/CIRCOUTCOMES.122.009787.
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^vi Szarek M, Bhatt DL, Miller M, et al. Effects of Icosapent Ethyl on Risk and Duration of Hospitalizations and Death in REDUCE-IT. Eur J Prev Cardiol. 2026 Jan 16:zwag040. doi: 10.1093/eurjpc/zwag040. Epub ahead of print.
^vii 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.
^viii 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.
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^xi Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
^xii 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.
^xiii Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease: New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.