ICER Determines OCA’s Benefit In NASH Might Support Limited Approval
The cost-effectiveness watchdog group sees the fibrosis benefit with Intercept’s obeticholic acid as supporting use in sicker NASH patients, but its overall risk-benefit ratio doesn’t merit broader use.
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The US FDA complete response letter for Intercept’s obeticholic acid raised speculation that the agency might be rethinking approvable endpoints for NASH. But analysts generally think OCA’s unspectacular efficacy data is behind the decision.
With approval timeline for OCA now thoroughly unclear and Genfit on the ropes, might the top spot in NASH end up with Galmed, AbbVie, Madrigal, Inventiva or Gilead instead?
Genfit SA is now pinning its hopes for elafibranor on primary biliary cholangitis after the dual PPAR alpha/delta agonist failed in its Phase III RESOLVE-IT trial for NASH.