Amarin's Stock Takes a Hit as FDA Delays Vascepa's Label Review

Posted on August 09, 2019 by Medtech[y] Staff


Amarin's stock was down over 17% in Friday trading as the company announced that the FDA plans to hold an an advisory committee meeting (AdCom), tentatively scheduled for November 14, 2019, in connection with its review of the pending supplemental new drug application (sNDA) for expansion of Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study.

The expectation was that the FDA wouldn't convene an AdCom in connection with its review of the REDUCE-IT sNDA and make a decision on an expanded label for Vascepa by September 28, 2019.

This unexpected update has created fear in investors as what seemed like positive progress towards an expanded label is now murkier than previously thought.

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."

With these new updates and 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.

“We look forward to the planned advisory committee meeting as an opportunity to highlight the landmark REDUCE-IT data and the important role we expect Vascepashould play in the treatment of cardiovascular disease in appropriate patients,” stated John Thero, president and chief executive officer of Amarin. “We plan to continue to work collaboratively with the FDA on the pending REDUCE-IT sNDA while we prepare for a robust launch of REDUCE-IT data assuming approval of Vascepa before the end of 2019 for a cardiovascular risk reduction indication based on REDUCE-IT.”

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.