Briefing Summary: US FDA Posts Advisory Committee Materials for Intercept’s Obeticholic Acid for Primary Biliary Cirrhosis – APR 7, 2016 (GIDAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Thursday, April 7, 2016 Gastrointestinal Drugs Advisory Committee (GIDAC) meeting. The Committee will 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