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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In its third venture funding round, Terns adds backing from Deerfield in addition to Lilly’s investment. It licensed three non-alcoholic steatohepatitis candidates from the big pharma in 2018.
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.