Intercept’s OCA Facing Extended Approval Wait In NASH As Known Risks Swamp Uncertain Benefits
Obeticholic acid clinical outcomes data from Phase III trial are needed before approval, US FDA advisory committee says, but Intercept suggests future of ongoing study is in doubt if accelerated approval in nonalcoholic steatohepatitis is not forthcoming now.
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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.
Intercept’s OCA In NASH: When Hitting Surrogate Endpoint Is Not Enough For Accelerated Approval
Although US FDA reaffirmed its support of surrogate endpoints described in a 2018 draft guidance on NASH fibrosis, advisory committee members questioned the link to clinical benefit and said obeticholic acid’s serious risks made it difficult to consider the effect on the surrogate in a vacuum.
What Does The Negative FDA Review For Intercept’s OCA Hold For Other NASH Drugs?
An FDA advisory committee’s “no” votes for Intercept’s obeticholic acid in non-alcoholic steatohepatitis could augur tough reviews for other NASH candidates. But some could enjoy smoother regulatory tides than OCA.