Intercept’s NASH Drug Delayed By April Advisory Committee
US FDA sets 22 April for advisory committee review of obeticholic acid in NASH, though whether the extended review was due to scheduling issues or any questions about Intercept's application itself remain unclear.
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Patient-reported outcomes indicate patients don’t see itch as a major quality-of-life factor. Intercept also reports that adding earlier-stage patients to review of OCA shows better data on resolving NASH.
There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.