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Indications of Seladelpar

Indications and Usage

Seladelpar is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) who have had an inadequate response to UDCA, in combination with UDCA; or as monotherapy in patients who cannot tolerate UDCA.

This indication is approved under accelerated approval based on reduction in alkaline phosphatase (ALP). Improved survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Limitations of Use

Seladelpar is not recommended for patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).