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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.

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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.

Intercept CRL Likely About OCA-Specific Concerns, Not NASH Endpoints

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.

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