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...
