With the prospects for near-term approval of Intercept Pharmaceuticals, Inc.’s obeticholic acid (OCA) in nonalcoholic steatohepatitis (NASH) fibrosis considerably dimmed by a negative FDA review and advisory committee recommendation, the drug’s existing accelerated approval in a much smaller indication also may be at risk for lack of confirmation of clinical benefit after seven years on the market.
Intercept’s Ocaliva: ‘Dangling’ PBC Indication At Risk As Near-Term NASH Approval Looks Unlikely
Accelerated approval for primary biliary cholangitis in 2016 came with three postmarketing requirements, but studies were terminated early; firm working toward sNDA submission in 2023 for regular approval, but US FDA says reports already are overdue and it expects to take PBC indication back to an adcomm.
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