Amarin Corp Plc (AMRN)

[sstyles]

Eliot Brinton -- check out his post on the public docket and a draft of the slides he will present here: https://www.regulations.gov/document?D=FDA-2019-N-3936-0098

https://www.regulations.gov/document?D=FDA-2019-N-3936-0098

His post:
I am strongly in favor of FDA approval of the proposed indication for icosapent ethyl: To reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease, based on the results of the REDUCE-IT cardiovascular outcomes trial.
I will not re-state the published results of that trial (well known to the EMDAC), but want to highlight a few key considerations:
1. REDUCE-IT showed an unprecedented ASCVD benefit as a statin adjunct in its:
a. %RRR,
b. absolute risk reduction/number needed to treat, and
c. degree of statistical significance
2. REDUCE-IT data are corroborated by JELIS data:
a. using an essentially identical agent (pure EPA ethyl ester)
b. in a similar population (high ASCVD risk)
c. with similar achieved plasma EPA levels
d. with a similar %RRR
Both REDUCE-IT and JELIS showed excellent tolerability and safety of pure EPA ethyl ester, which is, in turn, corroborated by mankind's favorable experience with eons of fish consumption, which bodes well long-term widespread clinical use of these fish-derived compounds.
The first attached file is a draft of the slide presentation I plan to present at the open public hearing on November 14.
The other attached files are all publications from the JELIS trial, in case the EMDAC does not otherwise have ready access to them.
Attachments (12)