FDA Changed Course On Zontivity Because Of Skepticism Of Subgroups At High Levels
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Large, complex dataset supporting Merck’s vorapaxar NDA invited “slicing and dicing” of the data by the primary reviewers – and made weight-based restrictions a key issue at the late-cycle and advisory committee meetings. But unusual, late-in-the-game reviews by high level FDA officials led to a post-panel U-turn.
You may also be interested in...
Review Of Reviews: Drug Review Profiles 2014
Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2014.
Review Of Reviews: Drug Review Profiles 2014
Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2014.
Merck’s Zontivity Label Isn’t Weighed Down With Safety Language
FDA approves antiplatelet inhibitor with a label that makes little mention of the safety concerns seen in lightweight patients, despite a vibrant FDA and advisory panel discussion on how to present the unfavorable data, but the company still has a big marketing challenge ahead.