Amarin Reaffirms Commitment To Complete REDUCE-IT Cardiovascular Outcomes Study

(RTTNews) - Amarin Corp. Plc (AMRN), a cardiovascular health-focused biopharmaceutical company, Tuesday announced its continued commitment to completing the ongoing REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial) cardiovascular outcomes study.

Amarin said it has always been scientifically committed to the REDUCE-IT cardiovascular outcomes study, but previously expressed that it was considering not completing the study as planned due to difficulties obtaining an expanded indication for the drug from the U.S. Food and Drug Administration.

Now the firm has decided to continue the study due to the large unmet need for therapies to reduce residual cardiovascular risk in statin treated patients, and Amarin's belief that the REDUCE-IT study will demonstrate that Vascepa can meaningfully reduce cardiovascular risk as an add-on to statin therapy.

The decision is also partly due to Amarin's confidence that it can continue to improve operational cash flow while it completes the REDUCE-IT study.

REDUCE-IT is a multinational, prospective, randomized, double-blind, placebo-controlled study.

According to the company, this is the first prospective cardiovascular outcomes study of any drug in a population of patients who, despite stable statin therapy, have elevated triglyceride levels.

The REDUCE-IT study is being conducted with Vascepa (icosapent ethyl) capsules, a highly-pure EPA omega-3 prescription product. Vascepa is currently approved as an adjunct to diet to reduce triglyceride levels in adult patients with severely high triglyceride levels, based on results from the Phase 3 MARINE clinical trial.

Vascepa also showed favorable effects on triglycerides and a spectrum of other lipid, lipoprotein and inflammatory biomarkers in the Phase 3 ANCHOR clinical trial, which included patients with cardiovascular risk profiles under study in the REDUCE-IT trial.

Since an outcomes trial of Vascepa has not been completed, the effect of Vascepa on cardiovascular risk has not been determined.