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Intercept Plans To Refile OCA For NASH At US FDA With Consensus Reads Of Patient Biopsies

Executive Summary

Additional patients and more long-term data could also help make case for obeticholic acid. Intercept hopes to complete its review of the pivotal REGENERATE trial during H1 2022.

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Intercept’s OCA In NASH: ‘Modest’ Effect On Surrogate Comes With ‘Substantial’ Risks, US FDA Says

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Will Intercept’s New NASH Analysis Pass FDA’s Muster?

The new analysis of REGENERATE, based on an FDA-requested methodology, shows continued efficacy for OCA, but analysts were circumspect about whether the benefit/risk profile would sway the agency.

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