US FDA staff flag liver damage concerns about Intercept's NASH treatment

Intercept Pharmaceuticals

17/05/2023 14:13

May 17 (Reuters) - The U.S. health regulator's staff
reviewers on Wednesday raised concerns about potential liver
damage from using Intercept Pharmaceuticals Inc's  ICPT.O  oral
tablets for treatment of a type of fatty liver disease, sending
the company's shares 20% lower in premarket trade.
    A panel of outside advisors to the U.S. Food and Drug
Administration (FDA) are set to meet on Friday to discuss the
marketing application for obeticholic acid oral tablets, making
it the first advisory committee meeting for a drug to treat
nonalcoholic steatohepatitis (NASH).

 (Reporting by Sriparna Roy and Leroy Leo in Bengaluru; Editing
by Rashmi Aich)
 ((Sriparna.Roy@thomsonreuters.com;))