Amarin (AMRN) Says REDUCE-IT Study of Vascepa to Continue as Planned
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Amarin Corporation plc (NASDAQ: AMRN) announced that, as expected, the independent data monitoring committee (DMC) has completed its review of the first pre-specified interim efficacy analysis for the REDUCE-IT cardiovascular outcomes study and has recommended that the trial continue as planned without modification. The 8,175-patient outcomes study is evaluating whether treatment with Vascepa® (icosapent ethyl) reduces cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors.
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. Amarin anticipates that the onset of approximately 80% of events will occur in the first half of 2017, with the second pre-specified interim efficacy analysis and review by the DMC expected around mid-2017. Amarin will remain blinded to results of the study until after the study is stopped and the database is locked at either the second interim analysis or at the final analysis.
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 December 2011, and more than 23,000 patient years of study have been accumulated to date in the ongoing REDUCE-IT study. The review and recommendation of the DMC was made independently. Neither Amarin nor the FDA has reviewed the interim clinical results and neither participated in the DMC’s closed session deliberation.
“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 Steven Ketchum, Ph.D., president of R&D and chief scientific officer of Amarin. “We remain confident that the REDUCE-IT study is positioned for success based on our extensive review of existing data from clinical, epidemiologic and genetic studies, and we look forward to the study’s anticipated completion. We continue to expect the onset of the final primary cardiovascular event to occur in the second half of 2017 with the publication of results anticipated in 2018.”
Residual Cardiovascular Risk in Statin-Treated Patients
Cardiovascular disease remains the leading cause of death in the United States, with the estimated costs of treating heart attacks, strokes and other cardiovascular disease manifestations exceeding $300 billion annually.1 In the United States, more than 35 million patients are treated with statins for the primary and secondary prevention of atherosclerotic cardiovascular events, including heart attacks and stroke.2,3 Despite the demonstrated clinical benefits of lowering bad cholesterol (LDL-C) with statins, 60% to 75% residual cardiovascular risk remains for statin-treated patients.4,5,6 Vascepa is being studied in REDUCE-IT as an add-on to statin therapy to further reduce cardiovascular risk, not as a replacement for statin therapy.
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 FDA.
Additional information on the REDUCE-IT trial and Amarin's other clinical studies of Vascepa can be found at www.clinicaltrials.gov.
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