Amarin Corp Plc (AMRN)

[Atom0aks]

Atom. To clarify my earlier post

I think the voting question will be something like
Should the label cover all those with clinical ASCVD and all those diagnosed with diabetes plus one additional risk factor .... all of whom are on statin therapy with TG’s over 135 mg / dL .

The answer imho will be a unanimous yes vote .

Kiwi

I appreciate the optimism, but unfortunately, the data does not support a label for primary prevention because that population only showed a small improvement relative to secondary prevention as was outlined in the recent 10-Q (hyperlink; emphasis is mine),

for example, as prespecified and previously disclosed, the established cardiovascular (CVD) disease secondary prevention cohort, which represented approximately 70% of enrolled patients in REDUCE-IT and had a high observed event rate, experienced a numerically higher effect size (27% relative risk reduction, or RRR) than the high-risk, mostly diabetic primary prevention cohort, which represented approximately 30% of enrolled patients and had a relatively lower observed event rate and experienced a 12% RRR;

As others have pointed out, expansion of the label to include the primary prevention criteria would tremendously increase the target population. Therefore, due to the potentially large population in contrast to the modest benefit, I am hypothesizing this is the question the FDA is looking to resolve with the AdCom.