DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that data evaluating the role of VASCEPA®/VAZKEPA® (icosapent ethyl) and eicosapentaenoic acid (EPA) in reducing cardiovascular events in at-risk patients will be presented at the joint ACC.23 together with the World Congress of Cardiology (ACC.23/WCC) in New Orleans, LA, March 4-6, 2023.
The featured research includes an analysis from the landmark REDUCE-IT trial on the effects of VASCEPA/VAZKEPA (icosapent ethyl) in patients with recent acute coronary syndrome (<12 months before randomization) and an assessment of the mechanistic activity of EPA in cardiovascular event risk reduction.
“We are delighted to share new findings from the REDUCE-IT trial and add to the wealth of data that has consistently validated the utility of icosapent ethyl in treating patient sub-populations at high risk for cardiovascular disease,” said Nabil Abadir, MB. CH.B., Chief Medical Officer and Head of Global Medical Affairs, Amarin. “This important information, coupled with the analysis comparing the antioxidant effects of EPA to docosahexaenoic acid (DHA) or mineral oil and corn oil, should help advance the medical community’s understanding of the role and value of icosapent ethyl and EPA to reduce cardiovascular events in at-risk patients globally.”
Featured Amarin-supported abstracts to be presented at ACC.23/WCC include:
Session 909 – Highlighted Original Research: Ischemic Heart Disease and the Year in Review
Room 219 at 10:21 – 10:30 AM
Sunday, March 5, 2023
Benefits of Icosapent Ethyl in Patients With Recent Acute Coronary Syndrome (ACS): REDUCE-IT
ACS – presented on behalf of all authors by Phillippe Gabriel Steg
Université Paris – Cite, France
Session 1255 – Valvular Heart Disease: Population Science 2
Poster Hall: Hall F at 10:45 - 11:30 AM
Saturday, March 4, 2023
Eicosapentaenoic Acid (EPA) Modulated Expression of Proteins Linked to Platelet Activation and Thrombosis in Vascular Endothelial Cells during Inflammation – presented on behalf of all authors by Preston Mason
Department of Medicine, Brigham & Women’s hospital, Harvard Medical School
Session 1691 – Vascular Medicine: Basic and Translational Science 15
Poster Hall: Hall F at 9:45 – 10:30 AM
Monday, March 6, 2023
Comparing the Effects of Pharmaceutical Grade Mineral Oil, Corn Oil, Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) in a Model of Atherosclerosis In Vitro - presented on behalf of all authors by Preston Mason
Department of Medicine, Brigham & Women’s hospital, Harvard Medical School
Session 1082 – Novel Vascular Pharmacotherapeutics
Pulmonary Vascular Disease, Valvular Heart Disease, Special Topics Moderated Poster Theater 4
Hall F at 10:00 - 10:10 AM
Monday, March 6, 2023
Moderated oral poster presentation
Pharmaceutical Grade Mineral Oil and Corn Oil Do Not Influence Phospholipid Membrane Oxidation Rates Compared to Omega-3 Fatty Acids In Vitro - presented on behalf of all authors by Samuel C.R. Sherratt
Elucida Research, Beverly, MA, USA
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our foundation in scientific research to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk.
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, a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after 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 over 18 million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, icosapent ethyl is approved and sold in the United Kingdom, Canada, Austria, Denmark, Finland, Lebanon, Germany, Sweden and the United Arab Emirates. 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 (icosapent ethyl) was granted in Great Britain. The Great Britain Marketing Authorization for VAZKEPA applies to England, Scotland and Wales.
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.
For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please click here.
Globally, prescribing information varies; refer to the individual country product label for complete information.
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 2022 and the potential impact and outlook for achievements in 2023 and beyond; Amarin’s 2023 financial outlook and cash position; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; and the overall potential and future success of VASCEPA/VAZKEPA and Amarin generally. 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 full year ended 2021. 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.
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