Intercept Says Data Indicate Pruritus Worries In NASH Could Be Overstated
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.
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Intercept said its commercial groundwork in NASH centered on identifying doctors who treat patients with advanced fibrosis and talking to payers about the importance of preventing cirrhosis.
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.
Intercept announced that the US FDA has set April 22 as date for an advisory committee review of OCA in NASH, meaning March 26 action date could be pushed back as much as three months.