Research and Development


Investor Alert
Vascepa® (icosapent ethyl) cardiovascular outcomes study, REDUCE-IT™, topline results are available.
See press release here

Amarin Corporation plc is a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health.

Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. We have conducted the first of its kind long-term, prospective cardiovascular outcomes study in high-risk patients on statin therapy, the REDUCE-IT study. The primary objective of this multi-center, randomized, double-blind, placebo-controlled study was to test the hypothesis that taking a pure, EPA-only omega-3 drug on top of existing statin therapy can provide a significant incremental reduction in cardiovascular events.

The REDUCE-IT (Reduction of Cardiovascular Events Outcomes) trial: A prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effectiveness of Vascepa® as an add-on to statin therapy in reducing the first major cardiovascular event in a high-risk patient population compared to statin therapy alone. REDUCE-IT results have been accepted for presentation at the 2018 Scientific Sessions of the American Heart Association (AHA) on November 10, 2018 in Chicago, Illinois. The presentation, classified as late breaking clinical trial results, is scheduled to commence at 2:16 pm Central Time and listed as Main Event 1 for the time frame. This acceptance as a presentation of late-breaking clinical trial results was granted based on the ability of REDUCE-IT to address a critical question in cardiovascular prevention.

Patients enrolled in the study had elevated triglyceride levels and at least one other defined cardiovascular risk factor. The control arm of the study was comprised of patients on optimized statin therapy. The active arm of the study was comprised of patients on optimized statin therapy plus Vascepa®. Entry requirements for participants in this study included elevated triglyceride levels and either coronary heart disease or risk factors for coronary heart disease. This 8,175 patient study had been conducted at over 400 clinical sites in 11 countries with the largest number of sites located within the United States.

REDUCE-IT was initiated in November 2011 and is now successfully complete with top-line results available in this press release.

The design of the REDUCE-IT cardiovascular outcomes study was published in March 2017 in Clinical Cardiology. For a summary of the article, please click here. A copy of this publication is available at: https://doi.org/10.1002/clc.22692. Copyright to this document is held by its publisher. This reference is provided for investors and should not be construed as marketing Vascepa® for the use under investigation in REDUCE-IT.

For more information, please visit https://www.clinicaltrials.gov/ct2/show/NCT01492361.

The efficacy and safety of Vascepa® were studied in two Phase 3 clinical trials, the MARINE trial and the ANCHOR trial. Both studies were conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). REDUCE-IT was also conducted under a Special Protocol Assessment.

  • FDA has not reviewed and opined on a new drug application related to the REDUCE-IT data. FDA has thus not determined whether to approve Vascepa® for use to reduce the risk of major adverse cardiovascular events in the REDUCE-IT patient population*
  • Additional updates on REDUCE-IT study results are planned in a peer-reviewed publication and presentation of REDUCE-IT results will occur at the late-breaker session at the 2018 Scientific Sessions of the American Heart Association (AHA) on November 10, 2018 in Chicago, Illinois
  • As with any topline CV outcomes trial result, further REDUCE-IT data assessment and data release will yield additional useful information to inform greater understanding of study outcome
    • Detailed trial data assessment may take several months to complete and record
    • Aspects that could change and impact the final evaluation of the totality of the efficacy/safety data from REDUCE-IT may include some or all of the following:
      • The magnitude of the treatment benefit on the primary composite endpoint, its components, secondary endpoints and the primary and secondary risk prevention cohorts
      • Consideration of which components of the composite or secondary endpoints have the most clinical significance
      • The consistency of the primary and secondary outcomes
      • The consistency of findings across cohorts and important subgroups
      • Safety considerations and risk/benefit considerations
      • Consideration of REDUCE-IT results in the context of other clinical studies
      • Study conduct and data quality, integrity and consistency

The MARINE study: A Phase 3, multi-center, placebo-controlled, randomized, double-blind, 12-week study that treated patients with severe (≥500 mg/dL) hypertriglyceridemia, more commonly known as very high triglycerides, or VHTG, with 229 patients enrolled. The primary endpoint in the trial was the percentage change in triglyceride level from baseline compared to placebo after 12 weeks of treatment. In November 2010, Amarin reported top-line data for the MARINE trial which met its primary endpoints.

The MARINE trial demonstrated that Vascepa® significantly lowered triglycerides without increasing LDL-C (non-significant decrease of -2%). In addition, MARINE demonstrated a statistically significant decrease in multiple other important lipid biomarkers including non-HDL-C, apolipoprotein B (apo B), lipoprotein-phospholipase A2 (Lp-PLA2), very low-density lipoprotein cholesterol (VLDL-C), Total Cholesterol (TC) and high-sensitivity C-reactive protein (hsCRP).

Vascepa® (icosapent ethyl) capsules, a therapy approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with VHTG, the severe (≥500 mg/dL) hypertriglyceridemia patient population studied in the MARINE trial, is now available by prescription.

In the MARINE study, the only reported adverse reaction with an incidence >2% and greater than placebo in Vascepa® treated patients was arthralgia (2.3% for Vascepa® vs. 1.0% for placebo). There was no reported adverse reaction >3% and greater than placebo. These data are based on a pooled analysis of two clinical studies (MARINE and ANCHOR) that included patients with triglycerides values of 200 to 2000 mg/dL.

For more information about the currently approved label for Vascepa® see www.vascepa.com.

The results of the MARINE study were published online in the American Journal of Cardiology  in June 2011 and are available at: http://triglyceridespanel.ajconline.org/Content/PDFs/3-Bays-Eicosapentaenoic.pdf. Copyright to this document is held by its publisher. This reference is provided for investors and is not a substitute for the approved label for Vascepa®. Note that in publications about Vascepa® (icosapent ethyl) its clinical name is AMR101.

The ANCHOR trial: A multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal Phase 3 study in patients with high triglycerides (≥200 mg/dL and <500 mg/dL) who were also on statin therapy. 702 patients were enrolled in this trial. The primary endpoint in the trial was the percentage change in triglyceride level from baseline of Vascepa®-treated subjects compared to placebo after 12 weeks of treatment. In April 2011, Amarin reported top-line results from the ANCHOR trial. The ANCHOR trial met its primary and secondary endpoints.

One of the ANCHOR trial's key secondary endpoints was to demonstrate a lack of elevation in LDL-C in order to avoid offset to the target of cholesterol lowering therapy. The trial's non-inferiority criterion for LDL-C was met at both Vascepa® doses. For the 4 grams per day Vascepa® group, LDL-C decreased significantly (-6.2%, P=0.0067) from baseline versus placebo, demonstrating superiority over placebo.

Other secondary efficacy endpoints included the median placebo-adjusted percent change in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (apo B), and lipoprotein-associated phospholipase A2 (Lp-PLA2) and very-low-density lipoprotein cholesterol (VLDL-C).

In this trial, the safety profile of Vascepa® was comparable to placebo and there were no treatment-related serious adverse events. Vascepa® does not have an FDA-approved indication for use in this patient population due to uncertainty on the connection between triglyceride reduction and cardiovascular risk reduction.

The FDA has not approved Amarin’s sNDA for this indication citing that they first need to see demonstration that the improvement in biomarkers observed in the ANCHOR study translates into fewer cardiovascular events. Amarin is seeking such demonstration through its ongoing REDUCE-IT cardiovascular outcomes study. While the sNDA for the ANCHOR indication has not been approved, in March 2016, Amarin reached agreement with the FDA and the US government allowing truthful and non-misleading promotion to healthcare professionals of the FDA-reviewed and agreed effects of Vascepa® demonstrated in the ANCHOR clinical trial and presentation of the current state of scientific research related to the potential of Vascepa® to reduce the risk of cardiovascular disease including through use of peer-reviewed scientific publications of available data.

The results of the ANCHOR study were published online in the American Journal of Cardiology  in June 2011 and are available at: http://triglyceridespanel.ajconline.org/Content/PDFs/1-Ballantyne-Efficacy.pdf. Copyright to this document is held by its publisher. This reference is provided for investors and should not be construed as marketing Vascepa® for this indication.

For more information on published studies related to Vascepa® (icosapent ethyl) capsules, known in the scientific literature as AMR101, see Investor Relations - Publications.

This page was last updated on September 24, 2018.

The information on this website is accurate only as of the date above. Amarin undertakes no obligation to update or revise this information as future events or circumstances arise.

This website contains forward-looking statements, which are not promises or guarantees and involve substantial risks and uncertainties. A list and description of these risks and 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 above.

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