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.
At a 19 May meeting, 12 of 16 members of the Gastrointestinal Drugs Advisory Committee voted that the benefits of...
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