Amarin Corp Plc (AMRN)

[cmm3rd]

Question re definition of Primary vs Secondary prevention.

Are the two terms being used uniformly in the label discussion?

Is the "prevention" part of the definition a reference to CVD, alone, or is it a reference only to prevention of a MACE event?

Example:

50 y/o male with LDLc well-controlled on statin, trigs 140 mg/dL, undergoes calcium CT resulting in calcium score of 25 (according to Texas Heart Institute: "plaque present, mild heart disease, moderate risk of having heart attack" https://www.texasheart.org/heart-health/womens-heart-health/straight-talk-newsletter/do-i-need-a-coronary-calcium-score/), no history of angina, MI, or stroke, not diabetic, no smoking history, no obesity.

Presumably, this patient, because of the calcium score, has ascvd for purposes of discussing the Vascepa label.

In which category would this patient fall for purposes of the Vascepa label discussion? Because he has a Dx of CVD, but no history of a MACE event, would Rx of Vascepa be for "primary prevention" (of a first MACE event) or for "secondary prevention" (of additional CVD, "secondary" since he already has known CVD)?

I have always thought this hypothetical patient would be considered a "primary prevention" candidate (no matter how many additional risk factors are added, including diabetes, and even an angiography finding of 50% stenosis of the LAD), until a MACE event is added to the clinical presentation. I also thought this was the definition Dr. Brinton was using.

Inotherwords, the only patients who are considered a "secondary prevention" patient are those who have had a MACE event, regardless of what or how many risk factors they have.

Is this correct, and is this how Amarin, FDA and the panel members are using the terms?

It would seem scientifically ludicrous, in light of what is known about EPA (not limited to REDUCE-IT results), to deny a label for use in at least some "primary prevention" patients, e.g., those with known CVD, particularly if the patient has elevated trigs, diabetes, and other risk factors, such as smoking, obesity, and family history of MACE.

In this regard (if what I have thought are the definitions of the two terms is correct), perhaps EVAPORATE results will help persuade FDA to approve at least some part of a primary prevention label. Upon review of EVAPORATE inclusion criteria, it appears a history of MACE events was not required, though at least 20% stenosis on CTA is required.