BEDMINSTER, N.J., and DUBLIN, Ireland, Sept. 25, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the number of patients enrolled in the company's REDUCE-IT cardiovascular outcomes study of Vascepa ® (icosapent ethyl) capsules has surpassed 6,000.
The REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial) study is a multinational, prospective, randomized, double-blind, placebo-controlled, parallel-group study taking place at over 400 clinical sites in 11 countries to evaluate the effectiveness and safety of Vascepa ® (icosapent ethyl) capsules, as an adjunct to optimized statin therapy, in reducing the incidence of first major cardiovascular events in a patient population at high risk for such events. The control arm of the study consists of patients on optimized statin therapy plus placebo. The active arm of the study consists of patients on optimized statin therapy plus Vascepa 4g/day. The high-risk patient population in REDUCE-IT has both a mean and median baseline triglyceride (TG) level over 200 mg/dL, a level substantially above those from recently conducted outcomes trials of other prescription lipid modifying therapies. Furthermore, Amarin has taken steps to ensure that the final baseline TG levels remain above 200 mg/dL. In addition, all patients enrolled in the study have either documented cardiovascular disease (CVD) or are at high-risk for CVD.
The REDUCE-IT study is being conducted under Amarin's previously announced Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). An SPA agreement is an agreement with the FDA that the Phase 3 trial protocol design, clinical endpoints, and planned statistical analyses are acceptable to support regulatory approval. An SPA agreement is generally considered binding upon the FDA unless public health concerns unrecognized at the time of protocol assessment are evident."Reaching the 6,000 patient mark in the REDUCE-IT trial represents significant progress toward full enrollment and another significant highlight for Amarin in 2013," said Joseph Zakrzewski, Amarin's Chairman and CEO. "The results of REDUCE-IT may enable us to seek additional indications for Vascepa including cardiovascular risk reduction, which would represent a patient population estimated to be almost twice that of the combined indications studied in the MARINE and ANCHOR trials or approximately 70 million adults in the United States alone."