(Reuters) – The U.S. health regulator’s staff reviewers on Wednesday raised concerns about potential liver damage from using Intercept Pharmaceuticals Inc’s 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)
