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Elafibranor is indicated for the treatment of primary biliary cholangitis (PBC) in adult patients with an inadequate response to ursodeoxycholic acid (UDCA), either in combination with UDCA or as monotherapy in patients who cannot tolerate UDCA.
This indication was approved through the accelerated approval pathway based on reductions in alkaline phosphatase (ALP) [see Clinical Studies (14)]. It has not been demonstrated to improve survival or prevent hepatic decompensation events. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Elafibranor is not recommended for patients with or who develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).
FDA，2024.06
