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# Mirum’s Livmarli Gets Expanded Label
- URL: https://www.fdaweb.com/mirums-livmarli-gets-expanded-label/
- Published: 2024-07-25T12:00:00.000Z
- Updated: 2026-09-14T14:36:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157437

FDA has approved a Mirum Pharmaceuticals label expansion for Livmarli (maralixibat) oral solution for treating cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). The expanded label includes use in PFIC patients 12 months and older as well as a higher drug concentration formulation evaluated in the company’s MARCH Phase 3 study, according to the company. Livmarli oral solution is described as a once-daily, ileal bile acid transporter inhibitor previously approved for treating cholestatic pruritus in patients with Alagille syndrome three months of age and older.