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

 
• By Joseph Haas

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 willing to work with the FDA on limiting patient access...

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