MORRISTOWN, N.J., Sept. 13, 2024 (GLOBE NEWSWIRE) -- The Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S. Food and Drug Administration (FDA) met today to discuss Intercept’s supplemental New Drug Application (sNDA) for OCALIVA® (obeticholic acid, OCA) for the treatment of primary biliary cholangitis (PBC) – a rare, progressive disease that disproportionally affects women. The sNDA was submitted to support full approval of OCALIVA and to satisfy post-marketing requirements confirming a clinical benefit in patients with PBC.

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Company Statement on FDA Advisory Committee Meeting