Amarin's REDUCE-IT Data For Vascepa May Be Game-Changing, But Not Without Controversy
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.
You may also be interested in...
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.
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.
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.