Background Analysis: US FDA Advisory Committee to Review Intercept’s Obeticholic Acid for Primary Biliary Cirrhosis– APR 7, 2016 (GIDAC)
The US FDA has scheduled a Gastrointestinal Drugs Advisory Committee (GIDAC) meeting for Thursday, April 7, 2016 to discuss New Drug Application (NDA) 207999 for obeticholic acid for the treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA, submitted by Intercept Pharmaceuticals, Inc. (Intercept).
See the SAC Tracker report