Will Intercept Drop OCA For NASH Following Negative FDA Panel Review?

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 willing to work with the FDA on limiting patient access to OCA – the panel had discussed at length whether regular patient monitoring after start of treatment could mitigate a risk for drug-induced liver injury (DILI) – and added that it was not clear if Intercept could continue