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Pooled phase 3 data presented at North American Society for Pediatric Gastroenterology, Hepatology & Nutrition 2023 support the benefit-risk profile of the ileal bile acid transport inhibitor in treating the rare liver disease.
The FDA has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in patients 12 months of age and older with Alagille syndrome.
Approval heralds the second rare cholestatic liver disease indication for Bylvay in the U.S. after progressive familial intrahepatic cholestasis related pruritus in 2021 Immediate U.S. commercial... | June 13, 2023
Odevixibat is indicated for treatment of cholestatic pruritus associated with Alagille syndrome in patients as young as 12 months. It marks the second indication for the drug.
The approval makes odevixibat the second IBAT inhibitor approved for the rare genetic disease, with capability to benefit both liver damage and itch symptoms.