Before the US Food and Drug Administration’s Gastrointestinal Drugs Advisory Committee began voting 19 May on whether to recommend approval of Intercept Pharmaceuticals, Inc.’s obeticholic acid (OCA) in non-alcoholic steatohepatitis, the firm’s chief medical officer Michelle Berrey took the unusual step of more or less pleading with the agency for a positive outcome for the drug.
Granted a minute to address the committee before it took up a pair of voting questions, Berrey said Intercept was...