The FDA decides to hold an expert panel review of Vascepa after all — and Amarin shares tank on unexpected delay
Mark your calendars for November 14.
After slowly and cautiously raising its hopes to the point where company execs believed an AdCom on its supplemental label for Vascepa was “unlikely,” the biotech put out word late Thursday that the FDA has pencilled in an expert panel meeting for them in mid-November.
And investors — who were growing increasingly warm to the idea that the company could be on a cakewalk to a crucial, and potentially blockbuster, approval on the September 28 PDUFA date — panicked. Shares $AMRN plunged 22% on the news.
That PDUFA date next month?
You can probably scrap that as well.
Amarin does not expect the FDA to take action on the sNDA by the previously announced September 28, 2019 Prescription Drug User Fee Act (PDUFA) goal date. Amarin did not receive notice from the FDA of a PDUFA date extension. 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.
An AdCom on Vascepa isn’t necessarily the end of the world, by any means, for Amarin boosters. But it will be an opportunity for FDA investigators to air every question they have about the data and invite their experts to scrutinize any weak point in their application.
As it stands, the company has had every opportunity to boast of the significant cardio benefits their investigators reported on REDUCE-IT, and any word to the contrary could ding its prospects among payers. On the other hand, a clear vote in its favor would mark a big endorsement for the drug as Amarin beefs up its staff in preparation for a greatly expanded marketing campaign.