Amarin Corp Plc (AMRN)

[AVII77]

No Retinadoc, be careful here:

The big takeaway is that multiple large epidemiology studies show a DOSE DEPENDENT relationships with triglyceride levels and death. Given this as fact, it is not a giant intuitive leap to assume that decreasing trigs will decrease mortality. Reduce-it has in my mind put to rest the unfortunate idea that trigs are just a bystander marker and not causative of CVD mortality and morbidity.

R-IT does not establish trigs in the causative pathway such that it is a modifiable risk factor.

If it did, then people with high trigs could simply take a cheap fenofibrate (ACCORD Trail) or Niacin (AIM HIGH Trial) to reduce trigs and reduce risk of cardiac events.

There is some irony here (I love irony).

We argued during our ANCHOR ADCom that subgroup data from those same trials (the subgroups with high baseline trigs) point to the reasonable conclusion that lowering trigs in high trig patients would lower cardiac risk and thus Vascepa should be approved.

Now, we must argue that is not necessarily true.

Rather we must argue that reducing trigs (our ANCHOR target) isn't what causes Vascepa to be beneficial. The MOA of Vascepa is far more complex than that (the "inflamatory hypothesis" vs the "trig hypothesis") .

Amarin understands this subtle issue. They have emphasized that R-IT was not designed to test the trig hypothesis.

But the conclusion you draw (bolded in your quote above) is a leap. And that leap is dangerous in that it would open up any drug or OTC supplement that lowers trigs to piggyback off of the success of R-IT.