Panel To Weigh Amarin’s Expanded <em>Vascepa</em> Use Given Clinical Outcome Concerns

Panel To Weigh Amarin’s Expanded Vascepa Use Given Clinical Outcome Concerns

FDA advisors will discuss Oct. 16 whether Vascepa’s effect on reducing triglycerides is enough to overcome concerns about this surrogate endpoint not panning out in other drug’s clinical outcomes trials.

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will vote on whether the potential treatment effect of change in fasting triglycerides seen with Amarin Corp. PLC’s Vascepa (icosapent ethyl) is enough to grant it an expanded indication prior to the completion of a cardiovascular outcomes trial.

The lack of a completed outcomes study could be particularly controversial because other products approved based on a surrogate of...