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Indications of Odevixibat

Pruritus in Progressive Familial Intrahepatic Cholestasis (PFIC)

Odevixibat is indicated for the treatment of pruritus in patients with PFIC aged 3 months and older.

Use RestrictionOdevixibat may be ineffective in a subgroup of patients with PFIC type 2 who have specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump protein.

Cholestatic Pruritus in Alagille Syndrome (ALGS)

Odevixibat is indicated for the treatment of cholestatic pruritus in patients with ALGS aged 12 months and older.

FDA，2025.03