Amarin Corp Plc (AMRN)

[Atom0aks]

Atom ..its not an either / or question IMHO
ie Not ASCVD or diabetes with 1 additional risk factor

*—Clinical ASCVD includes acute coronary syndromes, or a history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin.Aug 15, 2014

Diabetics with one additional risk factor may have never had any of the above ...MI, Stroke etc ......but will be included in the label.

90% of those with diabetes have 1 additional risk factor ...often high blood pressure

So you combine those 2 groups Clinical ASCVD and diabetics with 1 additional risk factor ....all on some statin and all with TG's over 135 mg/dl ....that is a huge population .

If you are thinking the final Adcom vote will be wether to approve for primary prevention .....I wouldn't bet on that . Would be fantastic but IMHO unlikely .
It makes perfect sense to include primary prevention ...ie all on statins add Vascepa ...why wait for the ASCVD qualifying event ...BUT the basic ASCVD plus diabetic label is not a failure ...its still a huge population

Theres an ASCVD risk scale in primary prevention and those MD's that use that are IMHO are going to prescribe if you have elevated risk even if you aren't clinically ASCVD .

Note .." 80% of people with Type 2 diabetes have high blood pressure."...from a diabetes site ...theres you 1 additional risk factor ...the other 10 % is another type of risk factor
JMO
Kiwi

It is an "or." REDUCE-IT (hyperlink) had two populations,

1. 29.3% on the basis of primary prevention (i.e., patients had diabetes mellitus and at least one additional risk factor)
2. 70.7% were enrolled on the basis of secondary prevention (i.e., patients had established cardiovascular disease)

The secondary prevention showed greater benefit than the primary prevention population (27% vs 12% RRR, hyperlink). Therefore, you can't expect the FDA to lump them together under the same label.