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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Liver health key opinion leaders say pre-authorization, requirements for biopsies or sicker patients could limit early uptake of NASH drugs. Intercept’s OCA, Genfit’s elafibranor both seen as likely combo therapy components.
CDER’s postponing of meetings planned through the end of April likely means a later advisory committee date to review OCA in NASH. The US PDUFA date previously was pushed back to late June.
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.