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Amarin Enrolls 6,000+ in Outcomes Study

REDUCE-IT tests Vascepa and statin therapy

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Amarin Corp. has enrolled more than 6,000 patients in its REDUCE-IT cardiovascular outcomes study of Vascepa capsules. REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial) 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 capsules, as an adjunct to optimized statin therapy, in reducing the incidence of first major CV events in a patient population at high risk for such events.

The study is being conducted under Amarin’s previously announced Special Protocol Assessment (SPA) agreement with the FDA. An SPA agreement is an agreement with the FDA that the Phase III 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.

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