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.
You may also be interested in...
Keeping Track: Vascepa Adds CV Risk Reduction Claim And Submissions Pour Into FDA
The latest drug development news and highlights from our US FDA Performance Tracker.
Amarin Heads Into Vascepa Expansion Labeling Talks After Positive US FDA Panel Review
Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory committee members favored a broad claim for secondary and primary prevention reflecting the REDUCE-IT trial population, but some strongly opposed an indication that includes patients without established CV disease.
Amarin’s Vascepa Positioned For Broad CV Risk Reduction Claim Following US FDA Panel Nod
Despite FDA's concerns, advisory committee unanimously endorses Vascepa's labeling expansion, with 10 of 16 members also favoring approval for secondary as well as primary prevention even as several voiced misgivings about efficacy in the REDUCE-IT trial's lower risk cohort.