The FDA has once again raised safety concerns around the use of Intercept’s Ocaliva in NASH, concluding in briefing documents ahead of an upcoming advisory committee meeting that it “cannot justify OCA use in NASH subjects with Stage 2 or 3 fibrosis.”
Intercept’s push for an accelerated approval was first rejected by the FDA in 2020 after multiple delays. At the time,…
This story from endpts.com was posted on 2023-05-17 by @sunbeam.