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# FDA OKs Mirum’s Livmarli for Rare Liver Disease
- URL: https://www.fdaweb.com/fda-oks-mirums-livmarli-for-rare-liver-disease/
- Published: 2021-09-29T12:00:00.000Z
- Updated: 2026-09-14T17:16:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150253

FDA has approved Mirum Pharmaceuticals’ Livmarli (maralixibat) oral solution to treat cholestatic pruritus in patients with Alagille syndrome age one and older. Mirum [says](https://www.marketwatch.com/press-release/us-fda-approves-livmarli-maralixibat-as-the-first-and-only-approved-medication-for-the-treatment-of-cholestatic-pruritus-in-patients-with-alagille-syndrome-one-year-of-age-and-older-2021-09-29?tesla=y&ref=fdaweb.com) Livmarli is a minimally absorbed ileal bile acid transporter inhibitor. It is the only FDA-approved medication for this rare liver disease. As part of the approval, FDA gave Mirum a rare pediatric disease priority review voucher.

The agency’s approval of Livmarli was based on the pivotal ICONIC study as five years of data from supportive studies, Mirum says. The company says the ICONIC data demonstrated statistically significant reductions in pruritus, which was maintained through four years.