ICPT Intercept says FDA extends PDUFA date for obeticholic acid for PBC treatment
Intercept Pharmaceuticals announced that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act, PDUFA, date for its Priority Review of obeticholic acid, OCA, in primary biliary cirrhosis, recently renamed primary biliary cholangitis, PBC. In response to an information request from the FDA, additional clinical data analyses have been submitted. To provide time for a full review of the submission, the original PDUFA date of February 29 has been extended by three months, resulting in a new PDUFA date of May 29, 2016. The FDA has also notified Intercept of a planned advisory committee meeting date of April 7, 2016. Intercept is seeking approval of OCA for the treatment of PBC in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. :theflyonthewall.com
