FDA plans committee meeting for Amarin label expansion, shares sink

Amarin announced that it received notice today from the FDA that the agency plans to hold an advisory committee meeting, tentatively scheduled for November 14, in connection with its review of the pending supplemental new drug application for expansion of Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study. “Before this communication, the FDA had been silent as to whether it would convene an AdCom in connection with its review of the REDUCE-IT sNDA. The FDA expressed, based on the timing of its recent decision to convene an AdCom, that November 14th is the earliest date on which it could hold an AdCom due to scheduling constraints for such a meeting,” Amarin said in a statement. Accordingly, Amarin does not expect the FDA to take action on the supplemental new drug application by the previously announced September 28 PDUFA goal date. It said, “In light of the tentative AdCom date, Amarin anticipates that the PDUFA date will be extended, assuming a typical three-month extension, to a date in late December 2019. If so, this anticipated revised PDUFA date timing would offset three of the four months that were expected to be gained from FDA’s earlier determination to conduct a priority review of the REDUCE-IT sNDA. Prior to such determination, Amarin had expected a PDUFA goal date in January 2020, based on a standard 10-month review. Amarin plans to update the investment community after appropriately definitive information is available related to a new PDUFA date.”