Replies to post #214602 on Amarin Corp Plc (AMRN)

[relocatedmetsfan]

Mellow - I understand your argument, but watch our what you’re asking for.

Case in point... the CaPre Phase 3 study that will be completed around November will advertise their EPA:AA and hsCPR biomarkers along different milestones (4 weeks, 12 weeks, etc). If, for whatever reason, those biomarkers equate or surpass what Vascepa produced in REDUCE-IT, they have a case to not have to undergo their own CVOT.

[sts66]

I believe this ADCOM will be about introducing other biomarkers (EPA/AA, hs-CRP) as acceptable surrogate end points to approve drugs for CVD reduction

Not the time or place to do that, especially given lack of full understanding of EPA's MOA, and FDA has essentially said "no more surrogate biomarkers for showing reduced CVD risk, you must run a CVOT", I doubt that attitude will change. In any case, hsCRP would be a crappy one to use, it's affected by way too many other things besides CVD, and CANTOS showed that lowering hsCRP did not reduce 3-pt MACE except for a subgroup of "responders" that got levels < 2 (analysis was post ad-hoc), so FDA gave NVS a CRL for their sNDA. I think Lp-PLA2 levels will eventually become a widely accepted risk marker used by clinicians, assuming R-IT shows a correlation between levels and event rates, but that will just be a screening tool, not a new surrogate marker for FDA indications - same thing for EPA/AA ratio.