Amarin Corp Plc (AMRN)

[Atom0aks]

OneRag. just coming back to this briefly
I think Atom was referring to the diabetic plus 1 risk factor as his designated primary prevention group .
This is far less then the entire primary prevention group which is basically everyone on a statin who has not had an “ event “

Do you have a source for that definition? Here is the exact quote from the REDUCE-IT paper (hyperlink) regarding primary and secondary prevention cohorts,

Among the patients who underwent randomization, 70.7% were enrolled on the basis of secondary prevention (i.e., patients had established cardiovascular disease) and 29.3% on the basis of primary prevention (i.e., patients had diabetes mellitus and at least one additional risk factor).

This definition was also used in the most recent 10-Q (hyperlink),

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;

This language is also used on the Vascepa website (hyperlink),

Patients were eligible to enter the trial if they were at least 45 years of age and on stable statin therapy with fasting LDL-C levels of >40 and ≤100 mg/dL and fasting TG levels of ≥135 and <500 mg/dL. Patients also needed to have either established CVD (secondary prevention cohort), defined as documented history of coronary artery disease, cerebrovascular or carotid disease, or peripheral artery disease, or be at least 50 years of age with diabetes and at least one additional risk factor (primary prevention cohort).

Is it possible you're confusing "primary prevention" with "first events" as shown on slide 12 (hyperlink) and described here (hyperlink),

Among statin-treated patients with elevated triglycerides and cardiovascular disease or diabetes, multiple statistical models demonstrate that icosapent ethyl substantially reduces the burden of first, subsequent, and total ischemic events.

In regards to ezetimibe, I was responding to this comment (hyperlink),

Atom are U suggesting that the FDA will not include diabetics with 1 additional risk factor because the RRR is ONLY 12% ??

Ezetimibe is approved for what I recall is even less the that .

Ezetimibe does have a relative risk reduction (RRR) in cardiovascular outcomes that is less than Vascepa (6% in IMPROVE-IT vs 12% in REDUCE-IT), however, Ezetimibe is approved for dyslipidemia (hyperlink), not cardiovascular outcomes. Like Ezetemibe, Vascepa is approved for dyslipidemia (hyperlink), however, Amarin wants to expand the label to cover cardiovascular outcomes based on REDUCE-IT results. Therefore, I am indeed suggesting that the FDA is convening an AdCom because they do not think a 12% relative risk reduction in cardiovascular outcomes is sufficient for expanding the label to include the primary prevention cohort (i.e., patients had diabetes mellitus and at least one additional risk factor).