{"id":758508,"date":"2023-05-12T11:03:06","date_gmt":"2023-05-12T15:03:06","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/amarin-highlights-new-data-providing-potential-mechanistic-insight-into-vascepa-vazkepa-icosapent-ethyl-reduction-of-cardiovascular-events\/"},"modified":"2023-05-12T11:03:06","modified_gmt":"2023-05-12T15:03:06","slug":"amarin-highlights-new-data-providing-potential-mechanistic-insight-into-vascepa-vazkepa-icosapent-ethyl-reduction-of-cardiovascular-events","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/amarin-highlights-new-data-providing-potential-mechanistic-insight-into-vascepa-vazkepa-icosapent-ethyl-reduction-of-cardiovascular-events\/","title":{"rendered":"Amarin Highlights New Data Providing Potential Mechanistic Insight into Vascepa\u00ae\/Vazkepa\u00ae (Icosapent Ethyl) Reduction of Cardiovascular Events"},"content":{"rendered":"
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\n \u2014 New Research Demonstrates Multifactorial Beneficial Effects of VASCEPA\/VAZKEPA on Coronary Physiology and Plaque Progression \u2014<\/em>
\n \n <\/p>\n

\n –Data Further Advances Understanding of VASCEPA\/VAZKEPA Potential Mechanism of Action–<\/em>\n <\/p>\n

DUBLIN, Ireland and BRIDGEWATER, N.J., May 12, 2023 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today highlighted new data describing the benefits of VASCEPA\u00ae<\/sup>\/VAZKEPA\u00ae<\/sup> (icosapent ethyl) on coronary physiology, which was published in the European Heart Journal – Cardiovascular Imaging<\/em>, and plaque progression, which was presented at the American Heart Association\u2019s Vascular Discovery 2023 meeting in Boston, MA, May 10-13.<\/p>\n

The studies and their key findings follow:<\/p>\n

\n Benefit of Icosapent Ethyl on Coronary Physiology Assessed by Computed Tomography Angiography Fractional Flow Reserve: EVAPORATE-FFR<\/u>
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\n CT<\/u>
\n <\/sub>\n <\/p>\n

The EVAPORATE trial assessed the efficacy of VASCEPA\/VAZKEPA in reducing plaque burden among patients on stable statin therapy with known angiographic coronary artery disease (CAD). EVAPORATE demonstrated that in statin-treated patients, VASCEPA\/VAZKEPA significantly reduced plaque burden measured by serial coronary computed tomography angiography (CTA) compared with placebo.<\/p>\n

The objective of the EVAPORATE- FFRCT<\/sub> study, which appeared online in the European Heart Journal – Cardiovascular Imaging<\/em>, was to assess the impact of VASCEPA\/VAZKEPA on coronary physiology assessed by fractional flow reserve derived from coronary CTA data sets (FFRCT<\/sub>) using imaging data from EVAPORATE.i<\/sup> FFRCT<\/sub> has been associated with various clinical outcomes, such as the safe deferral of invasive coronary angiography, cardiovascular death or myocardial infarction, and revascularizationii<\/sup>,<\/sup>iii<\/sup>.<\/p>\n

This study is the first assessment of FFRCT<\/sub> to determine drug effect, and there was significant improvement in the pre-specified primary endpoint of FFRCT<\/sub> value in the distal coronary segment from baseline to follow-up in the most diseased vessel per patient using VASCEPA\/VAZKEPA compared with placebo. VASCEPA\/VAZKEPA improved mean distal segment FFRCT<\/sub> at 9- and 18-months follow-up compared with placebo (P = 0.02, P = 0.03 respectively). The secondary endpoint, change in translesional FFRCT<\/sub> (\u0394 FFRCT<\/sub> across the most severe (minimum 30%) diameter stenosis) coronary lesion per vessel was improved with VASCEPA\/VAZKEPA treatment compared with placebo, although it was not statistically significant (P = 0.054).<\/p>\n

\u201cThe early and sustained improvement in FFRCT<\/sub> at 9- and 18-months follow-up provides mechanistic insight into the clinical benefit observed in the REDUCE-IT trial, which demonstrated that VASCEPA\/VAZKEPA significantly reduced ischemic events in statin-treated patients with atherosclerosis or diabetes and elevated triglycerides, including large reductions in myocardial infarction and elective, urgent, and emergent coronary revascularization,\u201d said cardiologist Mark G. Rabbat, MD, Professor of Medicine and Radiology and Director of Cardiac Computed Tomography (CT) at Loyola University in Chicago and lead author of the study. \u201cAdditionally, as this is the first assessment of FFRCT<\/sub> to determine drug effect, it has potentially important implications in utilizing FFRCT<\/sub> to predict treatment response.\u201d<\/p>\n

\n Effect of Icosapent Ethyl on In Vivo Atheroma Progression and Inflammatory Protease Activity<\/u>\n <\/p>\n

This animal study found that VASCEPA\/VAZKEPA reduced in vivo plaque progression versus control (P=0.03) as measured by intravascular ultrasound (IVUS) and plaque cathepsin protease activity (P=0.005) measured by near-infrared fluorescence (NIRF) molecular imaging. On fluorescence microscopy, plaques from animals treated with VASCEPA\/VAZKEPA exhibited fewer macrophages (P=0.04). The findings were presented by Mohamad Kassab, MD, in an oral presentation at the American Heart Association\u2019s Vascular Discovery meeting on May 11, 2023.<\/p>\n

\u201cThis study, which shows that VASCEPA\/VAZKEPA reduces in vivo plaque progression, plaque cathepsin protease activity and plaque macrophages, provides novel experimental evidence supporting the anti-atherosclerosis and anti-inflammatory effects of the medication.<\/p>\n

However, in vivo mechanisms underlying these effects remain somewhat unclear,\u201d said Farouc Jaffer, MD PhD, Director, Massachusetts General Hospital Coronary Intervention and Chronic Total Occlusion PCI Program, Boston, Massachusetts.<\/p>\n

\u201cThese new findings from two different studies provide important mechanistic information about VASCEPA\/VAZKEPA and further elucidate its value in reducing cardiovascular events in at-risk patients,\u201d said Nabil Abadir, MB. CH.B., Chief Medical Officer and Head of Global Medical Affairs, Amarin. “At Amarin, we\u2019re focused on improving the lives of those with cardiovascular disease. We are proud to add to the body of research that further demonstrates the benefit of VASCEPA\/VAZKEPA.”<\/p>\n

\n About Amarin<\/strong>
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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.<\/p>\n

\n About Cardiovascular Risk<\/strong>
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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.iv<\/sup>\u00a0And 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.<\/p>\n

Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient\u2019s 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%.v<\/sup>\u00a0Significant 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.vi<\/sup>,<\/sup>vii<\/sup>,<\/sup>viii<\/sup><\/p>\n

\n About REDUCE-IT\u00ae<\/sup><\/strong>
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REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg\/dL (median baseline 75 mg\/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg\/dL (median baseline 216 mg\/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).<\/p>\n

REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.ix<\/sup>\u00a0The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.x<\/sup>\u00a0The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.xi<\/sup>\u00a0These and other publications can be found in the R&D section on the company\u2019s website at\u00a0www.amarincorp.com<\/a>.<\/p>\n

\n About VASCEPA\u00ae<\/sup>\/VAZKEPA\u00ae<\/sup> (icosapent ethyl) Capsules<\/strong>
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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\u2019s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (\u2265500 mg\/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than 20 million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, icosapent ethyl is approved and sold in Canada, 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. VAZKEPA is being commercialized in multiple European countries, including England, Wales, Sweden and Finland.<\/p>\n

\n United States\u00a0<\/u><\/p>\n

Indications and Limitation of Use\u00a0
VASCEPA is indicated:\u00a0<\/p>\n