Intercept Pharmaceuticals saw a 16% drop in its stock value after an FDA advisory committee declined to approve obeticholic acid in pre-cirrhotic patients with liver fibrosis due to nonalcoholic steatohepatitis.
The vote before the Gastrointestinal Drug Advisory Committee on May 19 was Intercept’s second bid to put its 25 mg obeticholic acid product (Ocaliva) in a lead position as the first
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 Intercept’s drug did not outweigh the risks in NASH patients with fibrosis based on current data. Two members abstained.
Responding to the FDA decision Intercept CEO Jerry Durso said in a statement, “We are disappointed in the outcome of today’s meeting.”
“We continue to disagree with the FDA on certain characterizations of OCA’s efficacy and safety in pre-cirrhotic
(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