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Amarin's REDUCE-IT Data For Vascepa May Be Game-Changing, But Not Without Controversy

Executive Summary

CVOT results for Amarin's fish-oil pill show an unprecedented reduction in cardiovascular deaths. While questions have been raised about an LDL increase in the placebo group, an investigator says the overall results are too good to be explained by a well-known mineral oil effect.

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Amarin’s Vascepa: US FDA Panel To Scrutinize Breadth Of CV Risk Reduction

REDUCE-IT enrolled a higher risk group than the broad population targeted by Amarin’s proposed indication statement, agency says; although reviewers conclude an interaction between the mineral oil placebo and statins cannot be excluded, any impact would have been small and unlikely to change overall treatment effect.

An AdComm After All: Amarin's Vascepa Labeling Update Now Delayed By FDA

The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.

Amarin Will Double Vascepa Sales Team In Big Bet On Supplemental Approval

Anticipating a label expansion this fall based on the REDUCE-IT cardiovascular outcomes study, Amarin will double its sales force and has raised revenue guidance. Approved to reduce very high triglyceride levels, Vascepa sales total $170m-$174m so far this year.

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