Amarin Corp Plc (AMRN)

[Atom0aks]

Atom, what is your prediction for the vote?

I currently predict that the vote could go either way.

My prediction recently decreased because REDUCE-IT is weak regarding benefits in subpopulations, and yet, it has been brought up twice in just the last week: in the 10-Q (hyperlink) and Grand Rounds (hyperlink). This makes me suspicious that the sNDA includes language for primary prevention, in which case it might go badly for Amarin if the voting question revolves around approving Vascepa for a population that showed only a modest benefit.

Kiwi's example of ezetimibe is an excellent model of how Amarin's AdCom could go due to some eerie similarities (underlined text are hyperlinks):

Ezetimibe (Zetia)
Approved label: Dyslipidemia
Cardiovascular outcome trial: IMPROVE-IT
RRR of cardiovascular outcomes: 6%
sNDA for cardiovascular outcomes: 2014
Advisory committee: December 2015
Question: "Do the efficacy and safety data from the IMPROVE-IT trial provide substantial evidence to support approval of a claim that adding ezetimibe to statin therapy reduces the risk of cardiovascular events?"
Vote: No (5-10)
Rationale: "Those who voted “NO” stated that the the results did not provide statistically persuasive evidence of benefit, especially from the standpoint of using a single trial to support approval, and were not convinced that the magnitude of the benefit seen was clinically meaningful." (emphasis is mine)
CRL: February 2016

Icosapent ethyl (Vascepa)
Approved label: Dyslipidemia
Cardiovascular outcome trial: REDUCE-IT
RRR of cardiovascular outcomes: 12%
sNDA for cardiovascular outcomes: 2019
Advisory committee: November 2019
Question: "Do the efficacy and safety data from the REDUCE-IT trial provide substantial evidence to support approval of a claim that adding icosapent ethyl to statin therapy reduces the risk of cardiovascular events in patients with diabetes mellitus and at least one additional risk factor?" (PROPOSED)
Vote: TBD
Rationale: TBD
CRL: TBD