Amarin Corp Plc (AMRN)

[Biobillionair]

Vu- FDA doesn't confuse wording.

They just used confusing wording later in the document.

Amarin states requested label clearly in Q & A... FDA is just plan confused.

BB

In bold red the Amarin wording is too vague for FDA approval.

Language proposed by Amarin for an expanded label for Vascepa is intended to reflect the patient
population studied in REDUCE-IT and the results of REDUCE-IT, in particular:
• Reduction in five-point MACE (MI, stroke, CV death, revascularization, hospitalization for unstable
angina),
• Not a replacement for statin therapy but as an incremental and separate prescription treatment
option for patients at risk for CV events,
• 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),
• 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 insurancerelated issues that we do not believe should be encouraged for a cost-effective drug like Vascepa,
and
• Emphasis in the label should be on 4 grams per day (2 grams twice daily).