Investigators to Present New REDUCE-IT Subanalysis of VASCEPA®/VAZKEPA® (icosapent ethyl) in Patients With and Without Coronary Artery Disease History and Mechanistic Data on Eicosapentaenoic Acid (EPA) at the American Heart Association’s (AHA) Annual Scientific Sessions
DUBLIN and BRIDGEWATER, N.J., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that investigators will present an additional subgroup analysis from the landmark REDUCE-IT outcomes trial in patients with and without coronary artery disease (CAD) history and mechanistic data on eicosapentaenoic acid (EPA) at the American Heart Association’s Scientific Sessions, November 16-18, 2024 in Chicago, IL.
"The data to be presented at the AHA Scientific Sessions continues to affirm the clinical utility and value of VASCEPA®/VAZKEPA® (icosapent ethyl), not only in the overall REDUCE-IT trial population, but also across various subgroups analyzed to date," said Steve Ketchum, PhD, Chief Scientific Officer at Amarin. "Data presented at AHA will showcase new evidence from the REDUCE-IT CAD subanalysis, highlighting the benefits of VASCEPA/VAZKEPA in secondary prevention patients, with and without CAD history."
Dr. Ketchum further added, "Additional data to be featured at the AHA Scientific Sessions include research highlighting the mechanistic effects of EPA, particularly its antioxidant effects in endothelial cells and the ability of EPA to impact the oxidation of Lp(a) particles. High Lp(a) concentrations are associated with increased CV event risk, and people with high levels face a 2-4 times greater risk of having an early event. With about 20% of the global population affected, research is crucial for understanding and addressing elevated Lp(a)."
"This latest research reinforces Amarin’s commitment to advancing cardiovascular care and enhancing the medical community’s understanding of the value, mechanism of action, and global potential of VASCEPA/VAZKEPA in reducing cardiovascular events in high-risk patients," concluded Dr. Ketchum.
Featured Amarin-supported abstracts to be presented by international academic collaborators at AHA Scientific Sessions 2024 include:
Moderated Digital Poster Presentations
Substantial Cardiovascular Risk Reduction with Icosapent Ethyl in Patients with Prior Cardiovascular Events Regardless of Coronary Artery Disease History: REDUCE-IT CAD -Presenter: Rahul Aggarwal, MD -November 16th, 2:50-4:15 PM -Location: Zone 3
Eicosapentaenoic Acid (EPA) Increases Expression of Nrf2-mediated Antioxidant Response Element (ARE) and Heme Oxygenase-1 in Cytokine-Activated Endothelial Cells -Presenter: R. Preston Mason, PhD -November 18th, 2:50-4:15 PM -Location: Zone 1, MDP 2
Poster Presentations
Lipoprotein(a) [Lp(a)]-Enriched Plasma Undergoes More Rapid Oxidation than Small Dense LDL-Enriched Plasma that is Inhibited by Eicosapentaenoic Acid (EPA) -Presenter: R. Preston Mason, PhD -November 17th, 3:15-4:15 PM -Location: Zone 1, Science & Technology Hall
About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. 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.
About Cardiovascular Risk Cardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year.1 And the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds.
Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.2 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.3,4
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 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, Lebanon 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 (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Denmark, Finland, Austria, the UK, Spain and the Netherlands.
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 click here.
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 the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. 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 2023. 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. Availability of Other Information About Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (www.amarincorp.com/investor-relations), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
1 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139-e596. 2 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343. 3Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145. 4 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.
