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

Company tells advisory committee it is unsure of continuing on to collect Phase III outcomes data in NASH without accelerated approval, which the panel voted against.

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FDA advisory panel decisively votes against recommending approval of OCA for NASH • Source: Shutterstock

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...

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