US FDA panel votes against accelerated approval of Intercept fatty liver drug

Intercept Pharmaceuticals

19/05/2023 21:44

May 19 (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  ICPT.O 
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)
 ((Sriparna.Roy@thomsonreuters.com;))