Replies to post #224041 on Amarin Corp Plc (AMRN)

[Atom0aks]

There is no comparison in these trials and you know it. Why did you not include the other non-diabetic population? You make it appear there would only be one question for one of the populations and make it appear negative.

That's because I am predicting the question will revolve around just one population. But that's not my word, it's Amarin's:

analyses of the degree of treatment benefit in the different patient populations (i.e., subgroups) studied in REDUCE-IT and the sufficiency of the efficacy findings to support indications and the appropriate wording thereof in light of the patient characteristics of the populations studied; 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;

[Atom0aks]

There is no comparison in these trials and you know it. Why did you not include the other non-diabetic population? You make it appear there would only be one question for one of the populations and make it appear negative. This other trial had over 40% of the patients discontinue because of side effects. That factors into how physicians would answer a questions and while we are at it 6% vs 12 % is very different.

Here is an example of what I am trying to say:

This is the label for evolocumab (Repatha):

REPATHA is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor antibody indicated:
• to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease. (1.1)
• as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C). (1.2)
• as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C. (1.3)

This is the label for icosapent ethyl (Vascepa):

VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. (1)

This is the label I am predicting Amarin wants:

VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated
• to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease or diabetes and at least one additional risk factor.
• as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.

I am predicting the AdCom is to address the population in blue, which had a 12% RRR in cardiovascular outcomes. That does not mean they can't get the label in red, which had a 27% RRR in cardiovascular outcomes. I am just saying that the FDA is deferring to a panel of experts on whether to include BOTH populations on the label. Does that make sense?