Replies to post #58135 on Amarin Corp Plc (AMRN)

[jessellivermore]

FF..

"A large part of me wonders if Vascepa will ever be approved as a triglyceride lowering agent, no matter how good the R-IT results are"

R-I is an outcomes study. The question it addresses is will Vascepa as an add on drug to patients at risk for CVD, on adequate statins, further lowered CVD risk.

The mechanism of action is not germane as long as it does not enter safety issues into the trial...The trig question is only of academic interest. So sleep peacefully.

":>) JL

[TortLaw]

Fishydigits: Re: Your question:"A large part of me wonders if Vascepa will ever be approved as a triglyceride lowering agent, no matter how good the R-IT results are."

Vascepa® is already FDA approved as a triglyceride lowering agent.

[sts66]

Overall, I agree with your train of thought - that targeting non-HDL-C is a better path than TGs - but there's a small problem IRL application - a normal lipid panel does not directly measure LDL-C, only TC, HDL-C and TGs, so there is no way for a PCP to distinguish non-HDL-C from LDL-C, both are wrapped up within the TC number.

However, I see no reason why AMRN could not alter their post R-IT sNDA to change the lipid target from TGs to non-HDL-C, as data from the trial will provide the numbers they need to do so.