Amarin Corp Plc (AMRN)

[rafunrafun]

Dear FDA Advisory Committee:

Regarding: EMDAC November 14, 2019 Silver Spring, MD REDUCE-IT Icosapent Ethyl results

I am excited to hear the FDA will be reviewing the data presented and published last year at AHA and extra data presented at ACC this year regarding REDUCE-IT.

Being a family practice clinician for 25 years and having a large population affected by Atherosclerosis and also Diabetes it was refreshing to see RX IPE have such significant effects when added to the standard of care in the population studied.

We struggle daily to encourage lifestyle management and atherosclerosis risk reductions (CV Death, revascularization, MI, Strokes and hospitalizations for MACE) and to know that this additional agent was highly effective is quite encouraging.

I hope based on the cardiovascular outcome trial REDUCE-IT an indication will be granted for those patients similar to those enrolled in this trial. Unfortunately in the current environment insurance companies will use any excuse to deny coverage for care or what they consider off label treatments if the FDA has not granted an indication.

We have seen Safety and CVOT trials with Diabetes drugs (SGLT2is and GLP1RAs) agents which have been granted FDA indications beyond Diabetes for renal protection and various MACE protections despite knowing the exact mechanism for that benefit for the medications in question. I hope it is also possible for a triglyceride lipid agent which has shown significant benefit in high risk populations to also have an extended indication.
Unfortunately, this year I have seen representatives of Astra Zeneca and Investigators in the STRENGTH trial saying REDUCE-IT had no benefit from IPE but rather danger from mineral oil. In a similar vein they could have said results of EMPA-REG were in danger from insulin and sulonylurea in the comparator group rather than benefit of empagliflozin??? Recently this month while attending the national AAFP meeting a speaker from Philadelphia stated the REDUCE-IT trial results were fabricated by investigators employed in the industry.

I hope the Advisory Committee will support an expanded indication of icosapent ethyl (Vascepa) for reduction of residual cardiovascular risk in our high risk patients.

Thanks for your time.
Sincerely,

Michael Cobble MD AAFP, FNLA
Adjunct Faculty University of Utah
Fellow National Lipid Assocation
Hypertension Specialist American Society of Hypertension

https://www.regulations.gov/document?D=FDA-2019-N-3936-0018