The European Commission gives green light to a proven new treatment to reduce cardiovascular events such as heart attacks, strokes and cardiac deaths1
VAZKEPA® (icosapent ethyl) is the first and only approved treatment in Europe to reduce cardiovascular risk in statin-treated adult patients who have elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and other high-risk characteristics as studied in REDUCE-IT.1,2
DUBLIN, Ireland Mar. 30, 2021 – Amarin Corporation plc today announced that the European Commission has approved marketing authorization for VAZKEPA® (icosapent ethyl) in the European Union as a treatment to reduce the risk of cardiovascular events in high-risk statin-treated adult patients who have elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor.1
In its decision granting marketing authorization1, the European Commission identified VAZKEPA (icosapent ethyl) as a new active substance.1 In its positive opinion recommending the granting of a marketing authorization, the European Medicines Agency (EMA) identified VAZKEPA as having a mechanism of action that is likely multi-factorial, proven to have beneficial effects on cardiovascular risk reduction.3
The marketing authorization of VAZKEPA comes after a decade of designing and conducting evidence-based cardiovascular clinical outcomes research. In the landmark cardiovascular REDUCE-IT study, icosapent ethyl achieved 25% relative risk reduction of cardiovascular events (cardiovascular death, non-fatal heart attack, non-fatal stroke, coronary revascularization, unstable angina).2 This also included relative risk reductions of 31%, 28% and 20% in heart attacks, strokes and cardiovascular deaths, respectively.2
Professor Gabriel Steg, co-author of the REDUCE-IT study and Chief, Department of Cardiology at Hôpital Bichat, Paris, commented, “The REDUCE-IT study shows icosapent ethyl can reduce CV events and has the potential to change the way residual cardiovascular risk is treated. The approval of icosapent ethyl can make a difference to patients who are at high-risk of suffering from a heart attack or stroke. European patients can be confident we have a new treatment that is backed by evidence-based data and European Guideline recommendations.”
The publication of this research has led to VAZKEPA being recommended for use in studied high-risk statin treated patients identified by elevated triglycerides (135 mg/dL to 499 mg/dL) by 15 global medical societies around the world including the European Society of Cardiology and the European Atherosclerosis Society.4,5
Strokes and heart attacks caused by cardiovascular disease (CVD) are the most common cause of death in Europe.6 The economic burden of CVD in the European Union exceeds €210 billion a year and is expected to increase over the coming decades.6
The marketing authorization is also timely in the wake of the COVID-19 pandemic, which has resulted in the reprioritization of clinical resources, leaving patients with serious cardiovascular disease to delay much needed medical help.7 Preventative care is needed for at-risk patients with cardiovascular disease, including LDL-cholesterol management and additional treatments for statin-treated patients with residual cardiovascular risk, identified by elevated triglycerides to address their unmet need.
Amarin’s president and chief executive officer John Thero added, “We began developing VAZKEPA in Europe more than a decade ago. We are very grateful to the many patients and physicians who contributed to the development and clinical study of VAZKEPA. VAZKEPA can help to reduce strokes, heart attacks and other major cardiovascular events in high-risk patients across Europe. We are dedicated to a rethinking of cardiovascular disease risk reduction in Europe with an emphasis on preventative care. Today’s announcement marks the start of a new era for cardiovascular risk reduction in Europe. We will work tirelessly throughout Europe to make VAZKEPA available to all patients who can benefit from this unique therapy.”
Amarin is a rapidly growing, innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing. In 2009, Amarin had fewer than twenty employees. Today, with offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland, Amarin has approximately 1,000 employees and commercial partners and suppliers around the world. We are committed to rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management.
This press release contains forward-looking statements, including statements about the potential of VAZKEPA to favourably affect cardiovascular risk in appropriate patients, expectations at Amarin that VAZKEPA will be part of a new era for cardiovascular risk reduction in Europe, and plans at Amarin to make VAZKEPA available to patients in need. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties that may individually or together impact the matters herein and cause actual results, events and performance to differ materially from such forward looking statements. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: delays due to COVID-19 restrictions, later arising data, regulatory reviews and pricing assessments, and the successful implementation of commercialization plans. 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 its most recent annual report on Form 10-K. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
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 Amarin Data on File – EMA Marketing authorization.
 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.
 Committee for Medicinal Products for Human Use (CHMP). Summary of Opinion (Initial Authorisation).; 2021. https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vazkepa_en.pdf. Accessed March 30, 2021.
 Amarin Data on File – Guideline Approvals.
 Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS guidelines for the management of dyslipidaemias: Lipid modification to reduce cardiovascular risk. Atherosclerosis. 2019;290:140-205.
 ESC Cardiovascular Realities 2020 - Flipsnack. https://www.flipsnack.com/Escardio/esc-cardiovascular-realities-2020/full-view.html. Accessed March 30, 2021.
 Fersia O, Bryant S, Nicholson R, et al. The impact of the COVID-19 pandemic on cardiology services. Heart. 2020;7:1359.