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

Consensus Method Shows Consistent Efficacy

 
• By Alaric DeArment

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.

Intercept announced a new analysis of the pivotal Phase III REGENERATE study • Source: Shutterstock

Intercept Pharmaceuticals, Inc. is hoping that a new analysis of the Phase III REGENERATE study of obeticholic acid (OCA) in non-alcoholic steatohepatitis (NASH) will pass muster with the US Food and Drug Administration when it resubmits its application, but analysts are uncertain that the data change the benefit/risk profile enough to warrant approval instead of another complete response letter (CRL).

Intercept announced on 7 July results of a new analysis of REGENERATE, based on a consensus panel method of reading biopsies rather than using a single central reader, from the...

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