Could Postponement of Intercept’s Expected NASH Panel Impact Its PDUFA Date?
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.
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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.