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MNBioMike

09/11/19 9:53 PM

#213886 RE: oneragman #213885

I'm sort of with you. If Repatha and others received "for statin intolerant patients" why wouldn't V? UNLESS, ALL other trials had an arm for this cohort.

Again, I'm just a big dummy CPA, so some smarty pants bio person is free to overrule me at any time..... I really only bring financial expertise and common sense.....

bfost

09/11/19 11:31 PM

#213893 RE: oneragman #213885

Ragman - What you say regarding statin intolerant patients certainly makes sense but without any data to support it I don't think the FDA gives us the label.
However, I would think that AMRN could come up with some data from RI to support it's use in statin intolerant patients.

We know 50% of patients started on a statin have stopped the med for whatever reason after 1 year
We also know that 10-20% of patients have a significant degree of statin intolerance. Many of these can remain on a statin at lower doses , changing the statin, or using supplements like Co Q10 which may help.

Given those large numbers of patients in an 8000+ patient study and assuming a ?10 discontinuation rate at some point you would think they could generate some data on folks who ended up on Vascepa alone?
Maybe they have that data but have not shared it yet?

BTW, I think many physicians would feel similar to myself and not hesitate to prescribe V alone in at risk statin intolerant patients off label.