FDA Advisory Committee date for obeticholic acid as a treatment for pre-cirrhotic liver fibrosis due to NASH.- Intercept Pharma
Intercept Pharmaceuticals, Inc. announced that the Gastrointestinal Drugs Advisory Committee (GIDAC) of the FDA will discuss Intercept’s new drug application (NDA) for obeticholic acid (OCA) as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH) on May 19, 2023. The Advisory Committee Meeting will be hosted as a virtual meeting.
“There are currently no approved treatment options for people living with NASH, a devastating disease and the most rapidly growing cause of liver transplantation in the U.S.,” said Jerry Durso, President and Chief Executive Officer of Intercept. “We look forward to the opportunity to discuss with the Advisory Committee our clinical trial data demonstrating the strong and confirmed antifibrotic effect of OCA, as well as its manageable safety profile in NASH.”
As previously reported, the Prescription Drug User Fee Act (PDUFA) target action date is June 22, 2023. The timeline for review of the NDA by FDA remains subject to change.
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