FDA schedules meeting to review Intercept's OCA

FDA's Gastrointestinal Drugs Advisory Committee will meet on April 7 to discuss an NDA from Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) for obeticholic acid ( DSP-1747) to treat primary biliary cholangitis (PBC).

The company is seeking approval of the oral farnesoid X receptor (FXR; NR1H4) to treat PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Its PDUFA date is May 29. ...