Icosapent Ethyl - More than Just a Fish Tale?

Abstract

Icosapent ethyl (Vascepa®) is a purified preparation of the omega-3 fatty acid eicosapentaenoic acid, which is marketed by Amarin Pharma. The product was initially approved by the U.S. Food and Drug Administration for the use of a high dose (4 g/day) in the treatment of hypertriglyceridemia. On the basis of the results of the REDUCE-IT trial, the agency later granted a label extension to include the additional indication of a reduction in risk of cardiovascular events in persons with serum triglyceride levels 150 mg/dl or greater and established cardiovascular disease or diabetes. Data supporting the efficacy of omega-3 fatty acids in the prevention of cardiovascular disease have been inconsistent and controversial. The story of the development of icosapent ethyl has been fraught with challenges, including the invalidation of six core patents on the product, and recently, the completion of a new clinical trial, STRENGTH, that directly contradicts REDUCE-IT and calls into question whether icosapent ethyl is actually effective in the secondary prevention of cardiovascular events. This article traces the course of the development of this fascinating product and discusses lessons that can be learned from its complex history, which is still continuing to unfold.