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Re: HinduKush post# 323227

Wednesday, 02/03/2021 5:09:24 PM

Wednesday, February 03, 2021 5:09:24 PM

Post# of 427286
Nice list of what you define as a high CVD risk patient, but unfortunately none of that is on the EU label, which AMRN believes will say:

Based on communications with the EMA we expect the indication language to be generally consistent with the following:

That marketing authorisation be granted to icosapent ethyl to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL), and

established cardiovascular disease, or
diabetes, and at least one other cardiovascular risk factor.




That "and" is a major caveat - no preventive use unless you're diabetic - many/most of the people on this board would not qualify for a V script under those conditions. We could debate whether not saying "max tolerated statin dose" is good or bad - you could easily read the above to say "you must be on a statin to qualify". More than enough people in the EU meet those qualifications for AMRN to succeed, but unlike in the US they won't be able to capture off label but close to on label patients - like me.

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