Research presented at the American Heart Association’s Scientific Sessions on Quality of Care and Outcomes Research (QCOR) indicates the potential of VASCEPA® (icosapent ethyl) to reduce major adverse cardiovascular (CV) events and costs associates
DUBLIN, Ireland and BRIDGEWATER, NJ, May 16, 2022 (GLOBE NEWSWIRE) — Amarin Corporation plc AMRN today announced that research into the potential population health impact and cost-effectiveness of VASCEPA® (icosapent ethyl), featured in two poster presentations at the Quality of Care Research and Outcomes Scientific Sessions from the American Heart Association in Reston, Virginia on May 13-14, 2022 showed significant potential to reduce major cardiovascular (CV) events and associated costs.
The posters explored the potential of icosapent ethyl to prevent atherosclerotic cardiovascular disease events and associated costs in 3.6 million people.1 patients deemed eligible for treatment according to the criteria of the REDUCE-IT® trial and the cost-effectiveness of treatment with icosapent ethyl in suitable adult patients in the United States.
Abstracts supported by Amarin will be presented at #QCOR22 included:
- Presentation title: The potential population health impact of treating American adults with icosapent ethyl; Abstract identification number: 244; CG Derington, et al, presented on behalf of all authors by Catherine G. Derington, PharmD, MS, University of Utah, Salt Lake City, UT. Publication in the American Journal of Preventive Cardiology. 1Main conclusions: If the approximately 3.6 million US adults eligible for REDUCE-IT were treated for one year with PEI, 50,000 early and 97,000 total ASCVD events could be prevented. Each year, $3.4 billion from preventing a total of 97,000 events (first and recurrent) could be saved, resulting in a net burden of $2.6 billion. Annual indirect ($21.6 billion) and ambulatory ($23.5 billion) costs in this population are high. If a small proportion (eg, 5%) of outpatient and indirect costs are avoided with one year of treatment, then EPI is cost-effective therapy.
- Presentation title: Cost-Effectiveness of Icosapent Ethyl in Reduce-IT USA: Results from Randomized Patients in the United States; Abstract ID #170; Z. Zhang, et al, presented on behalf of all authors by Zugui Zhang, PhD, Christiana Care Health System, Newark, DE
Main conclusions: The REDUCE-IT USA cost-effectiveness analysis showed that IPE provides better results with lower costs, dominating both during the trial and for life as well as in the majority of sensitivity analyzes and sub- groups, both in primary and secondary prevention. These results, together with the clinical evidence of efficacy, suggest that at $4.16 per day, IE therapy should be strongly considered in patients similar to those enrolled in REDUCE-IT USA.
“The AHA has been a powerful voice in calling attention to the growing health and economic burden on patients and our healthcare systems due to the inadequate prioritization and management of heart disease and related risks,” said said Karim Mikhail, President and CEO of Amarin. “The analyzes presented at QCOR reinforce that icosapent ethyl, if prescribed and used consistently to treat eligible patients, can and should be an important tool to help reduce the staggering impacts and costs of disease. Cardiovascular in the United States”
1 Derington CG, Bress AP, Herrick JS, Fan W, Wong ND, Andrade KE, Johnson J, Philip S, Abrahamson D, Jiao L, Bhatt DL, Weintraub WS. The potential population health impact of treating REDUCE-IT-eligible US adults with icosapent ethyl. Am J Prev Cardiol 2022 [E-pub ahead of print]. https://doi.org/10.1016/j.ajpc.2022.100345.
Amarin is an innovative pharmaceutical company at the forefront of a new paradigm in the management of cardiovascular disease. 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 USA, Dublin in Ireland, Zug in Switzerland and other countries in Europe, as well as business partners and suppliers worldwide. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and to advancing the treatment of this risk.
About VASCEPA® (icosapent ethyl) capsules
VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) to consist only of the active ingredient, icosapent ethyl (IPE), a unique form of acid eicosapentaenoic. VASCEPA was launched in the United States in January 2020 as the first drug approved by the US FDA for the treatment of high-risk patients studied with persistent cardiovascular risk despite statin therapy. VASCEPA was originally 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 hypertriglyceridaemia (≥ 500 mg/dL). Since its launch, VASCEPA has been prescribed more than ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, Germany, Lebanon and the United Arab Emirates. In Europe, in March 2021, marketing authorization was granted for icosapent ethyl in the European Union for the reduction of the risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA.
Indications and limitation of use (in the United States)
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 at least two additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients with severe hypertriglyceridaemia (≥ 500 mg/dL).
The effect of VASCEPA on the risk of pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in patients with known hypersensitivity (eg anaphylactic reaction) to VASCEPA or any of its ingredients.
- VASCEPA was associated with an increased risk (3% versus 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was higher in patients with a history of atrial fibrillation or atrial flutter.
- It is unknown whether patients allergic to fish and/or shellfish are at increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if reactions occur.
- VASCEPA was associated with an increased risk (12% versus 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was higher in patients receiving concomitant antithrombotic drugs, such as aspirin, clopidogrel or warfarin.
- Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more common 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 hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events can be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and concomitant anticoagulants and/or antiplatelet agents should be monitored for bleeding.
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including opinions about the potential of VASCEPA (marketed as VAZKEPA in Europe); beliefs about the role of icosapent ethyl (IPE) in appropriate patients with cardiovascular disease (CVD) and the potential impact on population health, economics, and cost, as well as general beliefs about safety and the efficacy of VASCEPA. These forward-looking statements are neither promises nor guarantees and involve substantial risks and uncertainties. A more detailed list and description of such risks, uncertainties and other risks associated with an investment in Amarin may be found in Amarin’s filings with the United States Securities and Exchange Commission, including Amarin’s Annual Report on Form 10-K for the full fiscal year ending in 2021. 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 any 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 material transactions that the company may enter into, such as mergers, acquisitions, divestitures, joint ventures or any material agreements that Amarin may enter into, modify or terminate. Availability of Other Information About Amarin communicates with its investors and the public using the Company’s website (www.amarincorp.com) and the Investor Relations website (investor.amarincorp.com), including, but not limited to, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. Information posted by Amarin on these channels and websites could be considered material information. Accordingly, Amarin encourages investors, the media and others interested in Amarin to regularly review the information posted on these channels, including the Investor Relations website. This list of channels may be updated from time to time on the Amarin Investor Relations website and may include social media channels. The contents of Amarin’s website or such channels, or any other website accessible from its website or such channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
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