(Reuters) – A panel of advisers to the U.S. Food and Drug Administration on Friday recommended holding off on an accelerated approval of Intercept Pharmaceuticals Inc’s oral drug for a type of fatty liver disease until more study data is available.
The panel of outside experts voted 15-to-1 against the approval for obeticholic acid (OCA) based on surrogate biomarker data suggesting it was likely to benefit patients with NASH (non-alcoholic steatohepatitis) and fibrosis, or scarring, of the liver.
(Reporting by Sriparna Roy and Leroy Leo in Bengaluru; Editing by Bill Berkrot)
