Correct. Amarin likely going after the monotherapy for statin intolerant patients label.
No one is debating the “incremental” piece of this, it’s the “separate” wording that makes me think the monotherapy is likely being pursued. Also, why the departure from the “as an adjunct” that has been previously present?
Doesn’t really matter, as TTE said, the key will be supply in 2022.
Mellow ...Lowering of LDL cholesterol is well established as a method of action in reducing the risk of CV events .
The MOA of Vascepa is not as completely understood ...or as widely accepted .. We know part of its MOA is the benefit of lowering high TG's ......but is there any benefit and if so how much in patients with TG's below 100 mg/dl ...below 80 mg/dl ?? etc
And if there is a benefit will low TG's ...is it mainly confined to those also on Statins ? ....as Dr Mason stated " Statins enhance the benefit of EPA "...or words to that affect
So there is no way IMHO you are going to get a label that does not include ....when used with Statins .
The question in my mind ...is if everyone on Statins should be prescribed Vascepa as an "add-on " JMO Kiwi
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