Despite decades of scientific advances and clear guideline recommendations, millions of patients at high risk for CVD remain untreated or undertreated. The latest 2026
“We do not need to wait for tomorrow’s breakthroughs to save lives today,” said
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
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
About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the
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.
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For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in
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
Amarin Contact Information
Media Inquiries:
PR@amarincorp.com
Investor Inquiries:
dsullivan@theequitygroup.com or crodriguez@theequitygroup.com
Investor.relations@amarincorp.com
i
ii Navar AM, Kolkailah AA, Gupta A, et al. Gaps in Guideline-Based Lipid-Lowering Therapy for Secondary Prevention in
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
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