Amarin Corp Plc (AMRN)

[Dancing in the dark]

“Following the approval of icosapent ethyl as an adjunct to maximally tolerated statin therapy for a broad range of patients at risk for cardiovascular disease, a common question from physicians has been, what is the mechanism behind the large reductions in cardiovascular events such as heart attacks and strokes seen in REDUCE-IT?” commented Deepak L. Bhatt, M.D., M.P.H., lead investigator of the REDUCE-IT trial. “Now we see that the benefits appear to be driven primarily by on-treatment EPA levels with icosapent ethyl, whereas changes in triglycerides levels and other cardiovascular risk markers, including LDL, HDL, apoB and CRP, appear to be responsible for a significantly lesser proportion of the overall observed benefits.”

MARINE label

could amarin seek that FDA remove the MARINE trial language and indication entirely from the vascepa label based upon this understanding of MOA, I.e., not changes in triglyceride levels but rather on-treatment EPA levels?