Research Presented at the American Heart Association’s Quality of Care and Outcomes Research (QCOR) Scientific Sessions Indicate Potential for VASCEPA® (icosapent ethyl) to Reduce Major Adverse Car
DUBLIN, Ireland and BRIDGEWATER, N.J., May 16, 2022 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) today announced that research on the potential population health impact and cost-effectiveness of VASCEPA® (icosapent ethyl), presented in two poster presentations at the American Heart Association’s Quality of Care and Outcomes Research Scientific Sessions in Reston, VA, May 13-14, 2022, showcased significant potential to reduce major cardiovascular (CV) events and associated costs.
The posters explored the potential for icosapent ethyl to prevent atherosclerotic cardiovascular disease-related events and associated costs among 3.6 million1 patients estimated to be eligible for treatment according to REDUCE-IT® trial criteria, and cost-effectiveness of treatment with icosapent ethyl among appropriate adult patients in the United States.
Amarin-supported abstracts to be presented at #QCOR22 included:
- Presentation Title: The Potential Population Health Impact of Treating US Adults with Icosapent Ethyl; Abstract ID#: 244; C.G. 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. 1Key Conclusions: If the estimated 3.6 million REDUCE-IT eligible US adults were treated for one year with IPE, 50,000 first and 97,000 total ASCVD events could be prevented. Annually, $3.4 billion from preventing 97,000 total events (first and recurrent) could be saved, resulting in a net burden of $2.6 billion. Annual indirect ($21.6 billion) and outpatient ($23.5 billion) costs in this population are high. If a small proportion (e.g., 5%) of outpatient and indirect costs are prevented with one year of treatment, then IPE is a cost-saving therapy.
- Presentation Title: Cost-Effectiveness of Icosapent Ethyl in Reduce-IT USA: Results from Patients Randomized 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, DEKey Conclusions: The REDUCE-IT USA cost-effectiveness analysis has shown that IPE provides better outcomes with lower costs, dominant both in-trial and lifetime as well as in the majority of sensitivity analyses and subgroups, both in primary and secondary prevention. These results, 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 increasing health and economic burden on patients and our health systems from inadequately prioritizing and addressing heart disease and related risks,” said Karim Mikhail, Amarin’s president and chief executive officer. “The analyses presented at QCOR reinforce that icosapent ethyl, if prescribed and used consistently to treat eligible patients, can and should be an important tool in helping to reduce the staggering impacts and costs of cardiovascular disease in the U.S.”
_______________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.
About Amarin 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® (icosapent ethyl) CapsulesVASCEPA (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 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 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.
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 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.
Forward-Looking StatementsThis 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 and economics and cost, 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 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. 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 (investor.amarincorp.com), 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.
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