Replies to post #5376 on Amarin Corp Plc (AMRN)

[Biobillionair]

Same document pg 16
"A preIND meeting was held on 14 July 2008. During the discussion, it was agreed that a single study could potentially suffice for the indication “as an adjunct to diet to reduce triglycerides in adult patients with very high >500 mg/dL triglyceride levels” provided that the results are robust. The agency defined robust results as: results that are statistically significant; results from a study with a low drop out rate; study results that are consistent across treatment centers; and results from a study with a large sample size. The Agency also confirmed requirements for NCE toxicology program."

"NCE toxicology"

Page 20
"The drug product from Amarin contains a purified icosapent ethyl. Icosapent ethyl (ethyl eicosapentaenoic acid or ethyl-EPA) is the ethyl ester of EPA. Icosapent ethyl acts as a prodrug for EPA, as it is hydrolyzed enzymatically by esterases, particularly pancreatic lipase, to liberate the free acid EPA"

"Prodrug" not EPA but prodrug Icosapent Ethyl....sound like NCE;)

Anchor study reviewed pages 28 to 41

Both efficasy and safety for Marine and Anchor in this review.
A review of the data set and the FDA should rubber stamp it. This document is new to my eyes, anyone know when the FDA posted it?

[zumantu]

If they can add add Acnchor to Label - wow

[stangish]

FYI, I believe the FDA has reviewed the Anchor indication. If you read the Medical Review by Dr. Chowdhury the redacted b4 statements all fit.


JZ had mentioned in the past that the anchor data (TG reduction, LDL reduction, etc) was a part of the Marine NDA package.

(Hence why they took so long to submit the marine NDA..Had to wait on the anchor trial)....

[studythosestocks]

Bio,

If I could bring up the following point. On both the 4/12 and 4/19 dates it states that "this supplement type does not usually require new labeling". I guess you could make an argument around the "usually" but I wouldn't bet that these two updates are to add Anchor findings onto the label. I am very hopeful that I am wrong however.

[AtlasSnuggled]

lots depends on the exact interpretation of phrase "at a minimum," more to the point that comma ...

which could simply refer to >50% REDUCE-IT enrollment

or which could imply " ~50% REDUCE-IT enrollment ( plus other conditions)"

Try reading it optimistically (wham) or pessimistically, it works both ways

RE
"This application also contained a study report, but not the dataset, for the ANCHOR trial. This trial was not considered pivotal to the efficacy claims of Vascepa for this NDA. The ANCHOR trial investigated patients with TG between 200 mg/dL and 499 mg/dL despite statin therapy. The applicant was told prior to this NDA submission that data from the ANCHOR trial would not be mentioned in the Vascepa labeling until, at a minimum, 50% enrollment of a cardiovascular outcomes trial was reached."