What Does The Negative FDA Review For Intercept’s OCA Hold For Other NASH Drugs?

23 May 2023

An FDA advisory committee’s “no” votes for Intercept’s obeticholic acid in non-alcoholic steatohepatitis could augur tough reviews for other NASH candidates. But some could enjoy smoother regulatory tides than OCA.

Comparative analysis — Analysts saw FDA panel as bad news for FXR agonists, but not other NASH classes • Source: Shutterstock

While there is broad agreement that the 19 May US Food and Drug Administration advisory panel’s lopsided votes against recommending approval of Intercept Pharmaceuticals, Inc.’s obeticholic acid (OCA) for non-alcoholic steatohepatitis was a blow for that company, opinion is more varied about whether the Gastrointestinal Drugs Advisory Committee’s tight focus on safety and the clinical meaningfulness of meeting the surrogate efficacy endpoints will read through to other NASH drug candidates and their sponsors.

The committee voted 12-2 (with two abstentions) that Intercept’s drug – an oral FXR agonist now in its second FDA...