This American Heart Month Amarin Spotlights the Need to Prioritize Proven Widely Available Yet Underutilized Therapies in the Battle Against Cardiovascular Disease
DUBLIN and BRIDGEWATER, N.J., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a company committed to advancing the science of cardiovascular disease (CVD) worldwide, today issued a call to action for American Heart Month emphasizing a message that cannot wait: the United States has an opportunity to significantly reduce heart attacks, strokes, and cardiovascular deaths by prioritizing the use of proven, existing therapies that are widely available, yet significantly underutilized.
Despite decades of scientific advances and clear guideline recommendations, millions of patients at high risk for CVD remain untreated or undertreated. The latest 2026 American Heart Association (AHA) Heart Disease & Stroke Statistics show that CVD remains the leading cause of death in the U.S. and affects nearly half of the adult population. According to the AHA, 130.6 million U.S. adults (48.9%) were living with some form of CVD in 2023.i
"We do not need to wait for tomorrow's breakthroughs to save lives today," said Aaron Berg, President & CEO of Amarin. "With nearly half the nation affected by CVD, the need to deploy FDA- and EMA‑approved, foundational therapies with a history of reducing cardiovascular events such as heart attacks and strokes has never been greater. A real dent in cardiovascular disease can be made today – simply by using the tools we already have."
An Urgent, Persistent Unmet Need-Despite Available Solutions
Guideline‑supported, cost-effective therapies - including statins, ezetimibe, PCSK9 inhibitors, and icosapent ethyl - have a long and established history of robust evidence demonstrating reductions in cardiovascular events.
However, real‑world treatment patterns show: i,ii,iii,iv
- High‑risk patients frequently fail to achieve LDL‑C targets
- CV event rates among patients treated with statins who have established CV disease accumulate over time, with a cumulative incidence of CV events reaching up to approximately 40% over 10 years
- Few receive evidence‑based adjunct therapies
- There are still large gaps in prescribing across health systems
- Many patients continue taking treatments that lower biomarkers without improving clinical outcomes
This disconnect between evidence and practice represents one of the largest, yet immediately fixable unmet needs in modern medicine.
Innovation is Encouraging - But Patients Can Benefit From Available Life-Saving Treatments Today
While emerging research in pathways such as APOC3, ANGPTL3/4, CETP, and Lp(a) holds promise for the future, most innovations are years away from delivering proven clinical cardiovascular outcomes, reimbursement, and health system adoption.
Future innovation is essential, but immediate implementation of existing treatments saves lives. Patients can't afford to wait years for future evidence while their current cardiovascular risk goes untreated.
A 2026 Call to Action: Review, Reassess, Refocus
Amarin calls on the cardiovascular community to recommit to data‑driven care and to help patients, payers, and providers make informed decisions based on rigorous and validated clinical studies for currently available therapeutic options.
These critical gaps in care represent a national and global crisis of undertreatment in cardiovascular prevention, where patients who should be protected remain exposed.
This year, the call to action is clearer than ever: Review, Reassess, Refocus.
- Review current practice patterns to ensure alignment with latest guideline recommendations.
- Reassess therapies used primarily for lipid‑parameter changes without proven event reduction.
- Refocus on therapies backed by rigorous outcomes data to ensure real‑world practice reflects scientific consensus.
"This American Heart Month", says Aaron Berg, "we call on the cardiovascular community to act with urgency by prioritizing approved treatments already proven and widely reimbursed while advancing toward a future where cardiovascular disease is no longer the world's leading cause of death. We all have a role to play in evolving narratives. Together, we can save lives - right now."
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, CV.
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 was granted in the United Kingdom (applying to England, Scotland, Wales, and Northern Ireland). 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 key achievements in 2025 and the potential impact and outlook for achievements in 2026 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 September 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.
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]
i Palaniappan LP, Allen NB, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Bansal N, Currie ME, Earlie RS, Fan W, Fetterman JL, Barone Gibbs B, Heard DG,Hiremath S, Hong H, Hyacinth HI, Ibeh C, Jiang T, Johansen MC, Kazi DS, Ko D, Kwan TW, Leppert MH, Li Y, Magnani JW, Martin KA, Martin SS, Michos ED, Mussolino ME, Ogungbe O, Parikh NI, Perez MV, Perman SM, Sarraju A, Shah NS, Springer MV, St-Onge M-P, Thacker EL, Tierney S, Urbut SM, Van Spall HGC, Voeks JH, Whelton SP, Wong SS, Zhao J, Khan SS; on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Committee. 2026 Heart disease and stroke statistics: a report of US and global data from the American Heart Association. Circulation. Published online January 21, 2026
ii 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.
iii Bradley CK, Kolkailah AA, Shah NP, et al. Uptake of non-statin lipid-lowering therapies for secondary prevention in community practice. J Clin Lipidol. 2023;17(3):412-414. doi: 10.1016/j.jacl.2023.03.006.
iv Vijayaraghavan K, Baum S, Desai NR and Voyce SJ. Intermediate and long-term residual cardiovascular risk in patients with established cardiovascular disease treated with statins. Front. Cardiovasc. Med. 2024. 10:1308173. doi: 10.3389/fcvm.2023.1308173
