A US Food and Drug Administration advisory committee overwhelmingly voted against accelerated approval of Intercept Pharmaceuticals, Inc.'s obeticholic acid in nonalcoholic steatohepatitis (NASH), citing the currently unfavorable benefit-risk assessment and the need for outcomes data to determine if a positive effect on a histopathological surrogate translates into clinical benefit.
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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