VASCEPA (icosapent ethyl) Shows Significant Reduction in Coronary Revascularization, Including Coronary Stenting and Cardiac Bypass Surgery, in…

May 14, 2020 14:50 ET | Source: Amarin Corporation plc

First and total coronary revascularization event reductions of 34% and 36%, respectively, shown with VASCEPA in prespecified tertiary endpoint analyses

Results of prespecified tertiary endpoint analyses consistent across different types of coronary revascularization procedures, including urgent, emergent, and elective interventions

Percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) reduced by 32% and 39%, respectively, in post hoc exploratory analyses

DUBLIN, Ireland and BRIDGEWATER, N.J., May 14, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that data from the REDUCE-IT study presented by Benjamin E. Peterson, M.D., Brigham and Womens Hospital Heart & Vascular Center and Harvard Medical School, at the Society for Cardiovascular Angiography & Interventions 2020 Scientific Sessions, showed that administration of 4 g/day of VASCEPA (icosapent ethyl) resulted in a significant 34% reduction in first coronary revascularizations versus placebo (p<0.0001). Similar reductions of 36% were observed in total, or first and subsequent, revascularizations (p<0.0001).

These findings from the REDUCE-IT study put in further context the broad-reaching impact of icosapent ethyl on reducing the burden of cardiovascular disease for patients, commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Womens Hospital Heart & Vascular Center and Professor of Medicine at Harvard Medical School, and senior author of the REDUCE-IT REVASC analyses. To the best of our knowledge, this is the first non-LDL cholesterol intervention in a major randomized trial in which analyses support that statin-treated patients underwent fewer CABG surgeries, further highlighting the substantial impact of icosapent ethyl on the underlying atherothrombotic burden in this at-risk population.

Coronary revascularization procedures are invasive, carry multiple risks, and can have significant direct and indirect costs. Patients with elevated triglycerides despite statin therapy have increased risk for ischemic events, including coronary revascularizations. These procedures, whether pre-scheduled or performed in an emergency, oftentimes result in additional time spent in a healthcare setting.

The analyses from the REDUCE-IT study included several types of coronary revascularization events in statin-treated patients with persistent elevated triglycerides (135-499 mg/dL), who also had either cardiovascular disease or diabetes and additional cardiovascular risk factors. Prespecified tertiary endpoint analyses showed that times to first revascularization events were significantly reduced by VASCEPA versus placebo across subtypes of intervention, including urgent, emergent, and elective revascularizations, which were reduced by 34% (p<0.0001), 38% (p=0.02), and 32% (p<0.0001), respectively. In post hoc analyses, VASCEPA significantly reduced percutaneous coronary intervention (PCI) by 32% (p<0.0001) and coronary artery bypass grafting (CABG) by 39% relative to placebo (p=0.0005).

REDUCE-IT was not specifically powered to examine individual cardiovascular endpoints, therefore p-values presented for these revascularization analyses are nominal and exploratory with no adjustment for multiple comparisons. In addition, coronary revascularization as an endpoint can sometimes be considered subjective; however, these endpoints were adjudicated by an independent, blinded clinical endpoint committee. Results from the total coronary revascularization events analyses are consistent across the various recurrent event statistical models and are also consistent with the first coronary revascularization events results. Together, the REDUCE-IT first and total coronary revascularization events results support the robustness and consistency of the clinical benefit of VASCEPA therapy in reducing coronary revascularization.

Revascularization procedures significantly impact the healthcare system, said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. These data reflect new findings consistent with FDA-approved findings that continue to support that the use of VASCEPA has the potential to transform cardiovascular care in appropriate high-risk patients.

Slides from the presentation are available at http://www.scai.org/SCAI2020

About Amarin

Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health. Amarins lead product, VASCEPA (icosapent ethyl), is available by prescription in the United States, Canada, Lebanon and the United Arab Emirates. Amarin, together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, the European Union and the Middle East. For more information about Amarin, visit http://www.amarincorp.com.

About Cardiovascular Risk

The number of deaths in the United States attributed to cardiovascular disease continues to rise.1,2 There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are similar, accounting for 1 of every 19 U.S. deaths (approximately 1 every 40 seconds).3

Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patients 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% but that still leaves a 65-75% risk remaining.4 People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.5,6,7

About REDUCE-IT

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).

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.8The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.9The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.10 These and other publications can be found in the R&D section on the companys website at http://www.amarincorp.com.

About VASCEPA(icosapent ethyl) Capsules

VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was initially launched in the United States in 2013 based on the drugs 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 eight million times. VASCEPA is covered by most major medical insurance plans. The new, cardiovascular risk indication for VASCEPA was approved by the FDA in December 2019.

Indications and Limitation of Use

VASCEPA is indicated:

established cardiovascular disease or

diabetes mellitus and two or more additional risk factors for cardiovascular disease.

The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information

Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA, as set forth below:

Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT

n (%)

n (%)

(17.2)

(22.0)

(0.68, 0.83)

(11.2)

(14.8)

(0.65, 0.83)

(6.1)

(8.7)

(0.58, 0.81)

(5.3)

(7.8)

(0.55, 0.78)

(4.3)

(5.2)

(0.66, 0.98)

(2.6)

(3.8)

(0.53, 0.87)

(2.4)

(3.3)

(0.55, 0.93)

[2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization.

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT http://WWW.VASCEPA.COM.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the potential impact of VASCEPA in various clinical uses. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development and clinical trials such as further clinical evaluations failing to confirm earlier findings. 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 its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Amarins 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

Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor 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 Amarins investor relations website and may include social media channels. The contents of Amarins 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.

Amarin Contact Information

Investor and Media Inquiries:Elisabeth Schwartz Investor Relations Amarin Corporation plc In U.S.: +1 (908) 719-1315 investor.relations@amarincorp.com (investor inquiries) PR@amarincorp.com (media inquiries)

Lee M. Stern Solebury Trout In U.S.: +1 (646) 378-2992 lstern@soleburytrout.com

_____________________________ 1 American Heart Association. Heart Disease and Stroke Statistics 2019 Update: A Report from the American Heart Association. Published January 31, 2019. 2 American Heart Association / American Stroke Association. 2017. Cardiovascular disease: A costly burden for America projections through 2035. 3 American Heart Association: Heart Disease and Stroke Statistics -- 2019 At-a-Glance. 4 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. 5 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145. 6 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. 7 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563. 8 Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCEIT: Reduction of Cardiovascular Events with Icosapent EthylIntervention Trial. Clin Cardiol. 2017;40:138-148. 9 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22. 10 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and total ischemic events with icosapent ethyl across baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.

Read the original post:
VASCEPA (icosapent ethyl) Shows Significant Reduction in Coronary Revascularization, Including Coronary Stenting and Cardiac Bypass Surgery, in...