The U.S. Food and Drug Administration's staff reviewers on Tuesday supported the use of Intercept Pharmaceuticals Inc's liver drug as a monotherapy in patients who did not respond to standard-of-care treatment.
The drug, obeticholic acid, is being reviewed for use in patients with primary biliary cirrhosis, a rare liver disease resulting from an autoimmune destruction of the bile ducts.
The FDA staff reviewers said they were unable to assess the drug's safety in more severely affected patients and recommended a less frequent starting dose for such patients. (https://1.usa.gov/237TKZY)
A panel of outside advisers to the FDA is scheduled to meet on Thursday to vote on the drug. The FDA is not obliged to follow the advice of its advisory panels but it usually does so.
(Reporting by Amrutha Penumudi and Rosmi Shaji in Bengaluru; Editing by Anupama Dwivedi)