Amarin Corp Plc (AMRN)

[Mellowmood77]

So we now have a little more detail on what Amarin asked for in the original sNDA.

• Reduction in five-point MACE (MI, stroke, CV death, revascularization, hospitalization for unstable angina),

Self explanatory.

• Not a replacement for statin therapy but as an incremental and separate prescription treatment option for patients at risk for CV events,

HUGE! This is the MAIN reason for the ADCOM. From this statement it is apparent JT is going for the widest possible label (North of 70 million Americans).

• CV risk identified beyond cholesterol management to include patients with elevated TG levels and other CV risk factors, • TG levels of >135 mg/dL specified as that is the population studied in REDUCE-IT as elevated TG levels are a good identifier of risk (it being recognized that lowering TG levels alone are not validated as an FDA-approved surrogate for CV risk reduction, REDUCE-IT is not designed to validate TGs as a surrogate and the effects of Vascepa go beyond TG lowering),

Confirms previous point. States that having TG's above 135 puts you at RISK of CV disease and thus events. So putting the previous 2 bulletins together we can assume this statement:

Vascepa to be prescribed to patients with a TG level > 135. END OF STORY.

• Other CV risk factors are well understood by medical professionals and further delineation of such risks in the label is likely to clutter the label, confuse patients and lead to unnecessary insurance related issues that we do not believe should be encouraged for a cost-effective drug like Vascepa, and

Self Explanatory. Make it simple and truthful: Taking Vascepa if you have trigs greater than 135 will reduce risk of CV disease. Easy for everyone to understand, and no loopholes can be made not to prescribe if approved for this indication.

• Emphasis in the label should be on 4 grams per day (2 grams twice daily).

Self explanatory.


Ladies and gentlemen, I suggest you study up on the recent articles on Icosapent Ethyl's mechanisms of actions. THIS will be the main agenda of the ADCOM. NOT mineral oil.
Amarin will need to go into in depth explanations on how Vascepa lowers CV risk BEYOND LOWERING TG's.

Here is a good place to start:

https://link.springer.com/article/10.1007/s11883-019-0762-1

Most of these topics on MA will be fully discussed at the ADCOM.

Again, the ADCOM will be held to discuss in depth discussions of EPA's mechanism of action.