An AdComm After All: Amarin's Vascepa Labeling Update Now Delayed By FDA

The US Food and Drug Administration will convene its Endocrinologic and Metabolic Drugs Advisory Committee to review a critical labeling expansion for Amarin Corp. PLC's Vascepa (icosapent ethyl) for the treatment of severely high triglycerides, likely delaying approval of a supplemental new drug application (sNDA) based on the company's REDUCE-IT cardiovascular outcomes trial.

Amarin said after the stock market closed on 8 August that the US FDA informed the company it will hold an advisory committee meeting, but 14 November is the earliest date available