In accordance with the study protocol, the first interim efficacy analysis was performed after adjudication of approximately 60% of the target 1,612 aggregate primary cardiovascular events occurred within the study. Preparations for a second planned interim efficacy analysis will be triggered by the onset of approximately 80% of the target aggregate number of primary cardiovascular events.
The DMC's recommendation to continue as planned also reflects
its review of all available safety data. In accordance with the study protocol and DMC charter, safety reviews have been performed multiple times each year since REDUCE-IT began in
"We have accepted the independent DMC's recommendation, and we are pleased that REDUCE-IT continues as planned. We continue to anticipate that accumulation of additional cardiovascular events will add further robustness to the results of this important study which is the first outcomes study ever to evaluate
if the addition of pure EPA Vascepa to statin therapy confers a meaningful reduction in the occurrence of major cardiovascular events in patients with persistent elevated triglycerides and other cardiovascular risk factors," said
Residual Cardiovascular Risk in Statin-Treated Patients
Cardiovascular disease remains the leading
cause of death in
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 despite stabilized statin therapy have elevated triglyceride levels 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 (heart attack), nonfatal stroke, coronary revascularization, or hospitalization for unstable angina. Secondary endpoints include time to event analyses of components of the primary endpoint. The study is being conducted under a special protocol assessment agreement with the
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
1 Mozaffarian et al. Circulation. 2016;133: e43, e184.
2 NCHS Data Brief No. 177,
4 Hobbs FD, et al. BMC Med. 2016;14:4.
5 Cholesterol Treatment Trialists' (CTT) Collaboration, et al.
6 Koenig W. J Am Coll Cardiol. 2008;51(17):1642-4.
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 anticipated timing of cardiovascular events in REDUCE-IT and the timing of occurrence, assessment and publication of interim and final trial results from REDUCE-IT; the company's expectations that accumulation of additional cardiovascular events will add further robustness to REDUCE-IT study results; and the company's confidence in REDUCE-IT being positioned for success based on review of existing data from clinical, epidemiologic and genetic studies. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. For example, statements related to the potential efficacy and therapeutic benefits of Vascepa have been subject to different interpretations on matters such as the potential clinical importance of lowering triglyceride levels in studied
patients. Among the factors that could cause actual results to differ materially from those described or projected 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
Availability of other information about Amarin
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.
Amarin Contact Information:
Investor Relations and Corporate Communications
In U.S.: +1 (908) 719-1315
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