Livmarli

Treats cholestatic pruritus. NDA 214662, held by Mirum. Maralixibat Chloride.

As of Nov 14, 2026, NDA 214662 (Livmarli), held by Mirum, was first approved by FDA on Sep 29, 2021, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 29, 2021
Review: Priority
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

LIVMARLI is an ileal bile acid transporter (IBAT) inhibitor indicated for:

the treatment of cholestatic pruritus in patients 3 months of age and older with Alagille syndrome (ALGS).
the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC). o Limitations of Use: LIVMARLI is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of bile salt export pump (BSEP) protein. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below


Jul 24, 2024	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 13, 2024	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 13, 2023	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 29, 2021	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

2 strengths and forms


LivmarliEQ 9.5MG BASE/ML · solution;oral	Maralixibat Chloride	RxReference drug
LivmarliEQ 19MG BASE/ML · solution;oral	Maralixibat Chloride	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Nov 8, 2024	Supplement 11Labeling · Standard review	Approved	Label Letter
Jul 24, 2024	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 24, 2024	Supplement 9Manufacturing	Approved	Label Letter
Mar 13, 2024	Supplement 8Labeling · Standard review	Approved	Letter Label
Mar 13, 2024	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 13, 2023	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 1, 2022	Supplement 1Labeling · Standard review	Approved	Label Letter
Sep 29, 2021	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 214662
Drugs@FDA: Overview at FDA
Company: Mirum Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters