Payer KOL Says Expect “Levers” To Limit Early Uptake Of NASH Drugs
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.
You may also be interested in...
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.
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.
Genfit believes elafibranor’s clean tolerability and safety profile may help narrow the gap between it and Intercept’s OCA, with safety questions delaying OCA’s entry to market. Part two of Scrip’s interview with Genfit’s CEO and COO.