September 13, 2024 Meeting of the Gastrointestinal Drugs Advisory Committee (GIDAC)

The Committee will discuss supplemental new drug application (sNDA) 207999 S-011, for OCALIVA (obeticholic acid) 5 mg titrated to 10 mg oral tablets, administered once a day, submitted by Intercept Pharmaceuticals, Inc., to fulfill the accelerated approval postmarketing requirements specified in the OCALIVA approval letter dated May 27, 2016. The sNDA included data proposed to describe and verify clinical benefit for the indication for the treatment of adult patients with primary biliary cholangitis without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
Meeting Information and Materials: www.fda.gov/ad...