Intercept Retakes The Lead In NASH
Executive Summary
A week after Gilead missed its primary endpoint in the first Phase III NASH trial, Intercept shows a statistically significant fibrosis benefit in Phase III with OCA. It plans to file for approval later this year.
You may also be interested in...
Intercept Not Changing NDA Refiling Plans After OCA Misses NASH Cirrhosis Endpoint
Obeticholic acid failed to separate from placebo in a Phase III study of non-alcoholic steatohepatitis patients with cirrhosis, but Intercept said it still plans to refile an NDA for pre-cirrhotic NASH by year’s end.
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.
No Read-Through Expected: NASH Field Unfazed By Intercept’s FDA Rejection
Execs from Madrigal, Cirius and Axcella say the FDA’s complete response letter is specific to shortcomings of Intercept’s OCA – and leaves the race to be first to market wide open again.