Replies to post #207835 on Amarin Corp Plc (AMRN)

[AVII77]

A whole Adcom over mineral oil? What would that accomplish? Is anyone on committee going to come up with something not already discussed?

The committe isn;t going to come up with stuff. They will examine what the FDA reviewers have come up with.

We simply don't have all the data. The FDA does.

As ICER noted, an analysis was not presented showing results relative to hsCRP change at one year (in the same way they did LDL-c change in the NEJM paper).

And what about trigs? Hell, if MO blocks statin absorption and statins reduce trigs, why not look at those folks too (those control patients who had trig increases).

The FDA reviewers will slice and dice the data far beyond what a reviewer for the NEJM would request.

So what is the vote question?

Something like this:

DISCUSSION: Please comment on the design, conduct, and results of REDUCE-IT and whether REDUCE-IT…

a. Provides substantial evidence establishing that Icosapent Ethyl reduces the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction,or non-fatal stroke) in adults with elevated triglycerides and cardiovascular risk.

In your discussion, consider the patient population enrolled (e.g., baseline cardiovascular disease history), reliability of the results (e.g., potential impact of mineral oil placebo), the clinical meaningfulness of the results, and the consistency of the results across the components of the MACE endpoint and subgroups.

VOTE: Does the REDUCE-IT trial provide the substantial evidence needed to establish that Icosapent Ethyl 4 g daily reduces cardiovascular risk in statin treated patients with elevated triglycerides? Provide the rationale for your vote.

a. If yes, discuss the population for whom you believe this benefit applies.
b. If no, comment on what additional data would be needed.