BEDMINSTER, NJ (
President John Thero made news -- and not necessarily the good kind -- at an investor conference Thursday when he said the company was preparing for a Vascepa FDA advisory panel later this year.
A date for the FDA advisory panel has not been set, but Thero said the panel would review Amarin's prescription-grade fish oil pill for the so-called "Anchor" indication of treating patients with mixed dyslipidemia.
"There is an SNDA PDUFA date of December 20. Again, we are preparing for an advisory committee for that because it is the product that will be first in this indication for this class," said Thero, speaking at a healthcare investor conference Thursday sponsored by Jefferies.
I follow Amarin pretty closely but I can't recall executives discussing an FDA advisory panel for Vascepa in a public setting previously. This sounds like news to me.
In a research note dated April 8 following a meeting with Amarin management, J.P. Morgan analyst Chris Schott mentioned the possibility of an FDA panel for Vascepa.
Amarin bears (and yes, I'm one) believe
FDA is wary of approving Vascepa
for the larger mixed dyslipidemia patient population without definitive proof that the fish oil reduces the risk of heart attack, strokes and other cardiovascular events. The company is conducting a large cardiovascular outcomes trial of Vascepa, dubbed Reduce-It, but results won't be known until 2016.
An FDA advisory panel for Vascepa is a big risk for Amarin because experts could easily side with Cleveland Clinic cardiologist Dr. Steve Nissen, who opposes FDA approval of Vascepa's label without positive data from the Reduce-It study.
A Vascepa FDA panel later this year would convene with the torturous debate over the safety of the
(GSK - Get Report)
diabetes drug Avandia still fresh in everyone's minds. A desire to avoid another Avandia or
(MRK - Get Report)
Tredaptive is an argument for not expanding Vascepa's use without the cardiovascular outcomes data expected in 2016.
Amarin bulls believe FDA will approve Vascepa for the Anchor indication because the application and the Reduce-It study are covered under a Special Protocol Assessment agreement. But if that were true, why would FDA bother with convening an advisory panel?
Thero did not mention anything about a date for the Vascepa advisory panel during his presentation Thursday. FDA's endocrine division reviewed the original Vascepa approval application last year, but there are no tenative meeting dates for the Endocrinologic and Metabolic Drugs Advisory Committee scheduled for the rest of the year.
FDA could decide to have Vascepa reviewed by the Cardiovascular and Renal Drugs Advisory Committee, which has a tentative meeting scheduled for Aug. 5-7.
FDA could, of course, set up a meeting for the fall for either panel that is not currently on the agency's calendar.
-- Reported by Adam Feuerstein in Boston.