Significant Growth and Prescribing Patterns

Amarin's VASCEPA/VAZKEPA has established itself as a safe and effective oral therapy, prescribed over 25 million times globally. It is primarily indicated for those with severe hypertriglyceridemia (sHTG), defined as TG levels equal to or exceeding 500 mg/dL. This approval, supported by strong clinical evidence and broad reimbursement, positions VASCEPA favorably within payor-driven step therapy programs.

Applauding Scientific Advancements

Amarin commends the groundbreaking work addressing conditions such as sHTG and the rare genetic disorder familial chylomicronemia syndrome (FCS). These advancements bolster patient-doctor dialogues and focus on the risks associated with high triglyceride levels, which can lead to pancreatitis.

Aaron Berg, President and CEO of Amarin, stated: “Innovative therapeutics and related FDA breakthrough therapy designations highlight the focus on treating patients with elevated triglycerides. VASCEPA is approved in the U.S. to reduce triglycerides in patients with sHTG and has received cardiovascular risk reduction (CVRR) endorsements in over 50 countries.”

VASCEPA: Direct Impact on Cardiovascular Events

The application of VASCEPA extends to reducing cardiovascular (CV) events in patients identified as high-risk. The recent emergence of new ApoC-III–targeted injectables signifies a critical advancement, yet there remains a pressing need for effective therapies among millions of cardiovascular disease (CVD) patients worldwide with TG levels above 150 mg/dL.

VASCEPA, approved as an adjunct to diet and statin therapy, significantly reduces the risk of myocardial infarction, stroke, and other major CV events. The landmark REDUCE-IT trial, published in 2018 with 8,179 participants, showed a remarkable 25% reduction in cardiovascular events when VASCEPA was administered alongside statin therapy.

Strategic Expansion and Licensing Agreements

In a strategic move, Amarin expanded the global reach of its VASCEPA/VAZKEPA franchise in 2025 via an exclusive agreement with Recordati S.p.A. This deal allows for the commercialization of VAZKEPA across 59 countries, particularly in Europe, where patent protection lasts until 2039. Currently, VASCEPA/VAZKEPA is available in over 20 countries.

The Future of VASCEPA in Step-Therapy Programs

In the U.S., existing payor step-therapy programs for new ApoC-III injectables suggest a trend towards broader use of established drugs like VASCEPA, cementing its role as a first-line treatment. This framework mirrors the introduction of PCSK9 inhibitors in 2015, which coincided with a substantial growth in ezetimibe prescriptions, averaging approximately 15% annually.

As more FDA approvals for ApoC-III therapies emerge, the financially driven demands placed on providers could lead to increased recognition and utilization of VASCEPA/VAZKEPA as a cost-effective and clinically proven agent.

About Amarin Corporation

Amarin is dedicated to reducing the burden of cardiovascular disease (CVD) through comprehensive scientific advancements. The company supports its global branded product, which holds multiple regulatory approvals based on substantial efficacy and safety demonstrated through clinical trials. Amarin operates through a direct sales model in the U.S. and collaborates with experienced partners worldwide, covering nearly 100 markets.

Learn More About VASCEPA®/VAZKEPA®

VASCEPA (icosapent ethyl) capsules represent the first FDA-approved treatment solely utilizing icosapent ethyl, providing a significant therapeutic option for high-risk patients. Since its U.S. launch in 2020, VASCEPA has been prescribed extensively and is now available in various countries, marking a crucial step in addressing persistent cardiovascular risks despite statin therapy.