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By Leroy Leo and Sriparna Roy (Reuters) -A panel of advisers to the U.S. Food and Drug Administration, wary of the safety of Intercept Pharmaceuticals...
By Leroy Leo and Sriparna Roy (Reuters) -A panel of advisers to the U.S. Food and Drug Administration, wary of the safety of Intercept Pharmaceuticals’ oral drug for a type of fatty liver disease, recommended on Friday holding off on an accelerated approval of the medicine. 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. The panel by a wide 12-to-2 margin voted that the benefits of I...
(Reuters) -A panel of advisers to the U.S. Food and Drug Administration, wary of the safety of Intercept Pharmaceuticals' oral drug for a type of fatty liver disease, on Friday recommended holding off on an accelerated approval of the medicine. | May. 19
An FDA advisory committee voted against approval for obeticholic acid in pre-cirrhotic patients with liver fibrosis due to nonalcoholic steatohepatitis, citing “concerning” risk/benefit profile.
(Reuters) -A panel of advisers to the U.S. Food and Drug Administration, wary of the safety of Intercept Pharmaceuticals' oral drug for a type of fatty liver disease, on Friday recommended holding off on an accelerated approval of the medicine. | May. 19