The REDUCE-IT study is evaluating whether treatment with Vascepa reduces cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors.
"We are pleased to have completed the randomization of all patients into REDUCE-IT," said
While it is possible that the study could terminate early for overwhelming efficacy at either the 60% or 80% interim analysis, guidelines for the independent DMC to recommend stopping the study for overwhelming efficacy require that the study achieve a high level of statistical significance on the primary endpoint and generate other robust findings including on certain, pre-specified secondary outcome measures to support an overall favorable benefit/risk profile. Given the high threshold of overwhelming efficacy required for a DMC to recommend an early stop to a cardiovascular outcomes trial like REDUCE-IT,
REDUCE-IT is a global Phase 3, randomized, multicenter, double-blind, placebo-controlled study designed to evaluate whether treatment with Vascepa reduces cardiovascular events in patients who have persistently elevated triglyceride levels despite stabilized statin therapy and other cardiovascular risk factors. The primary endpoint of the study is the time to the first occurrence of the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina. Secondary endpoints include time to event analyses of components of the primary endpoint.
Additional information on the REDUCE-IT trial and Amarin's other clinical studies of Vascepa can be found at www.clinicaltrials.gov.
About Vascepa® (icosapent ethyl) capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of 1 gram of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex
Important Safety Information for Vascepa
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the
Amarin Corporation plc is a biopharmaceutical 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. Amarin's clinical program includes a commitment to the ongoing REDUCE-IT cardiovascular outcomes study. Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is a highly-pure, EPA-only, omega-3 fatty acid product available by prescription. For more information about Vascepa, visit www.vascepa.com. For more information about Amarin, visit www.amarincorp.com.
This press release contains forward-looking statements, including statements about the company's confidence in the design of REDUCE-IT and efforts to help ensure robust results; the timing of cardiovascular events in REDUCE-IT and the timing of occurrence, assessment and publication of interim and final trial results from REDUCE-IT; and expected outcomes from the REDUCE-IT DMC's interim analysis. 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 expected herein include uncertainties associated generally with complex clinical trials like REDUCE-IT and research and development and clinical trial risk generally; differing views on interpretation of clinical trial results; and reliance on third parties. 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.
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Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), 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 we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
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Kathryn McNeilInvestor Relations and Corporate Communications Amarin Corporation plcIn U.S.: +1 (908) 719-1315 firstname.lastname@example.org Lee M. Stern Trout GroupIn U.S.: +1 (646) 378-2922 email@example.com Media Inquiries: Ovidio Torres Finn PartnersIn U.S.: +1 (312) 329 3911 firstname.lastname@example.org
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