Drugdocs | Livmarli®

Drug updated on 3/28/2024

Dosage Form	Oral solution (oral; 9.5 mg/mL)
Drug Class	Ileal bile acid transporter inhibitors
Ongoing and Completed Studies	ClinicalTrials.gov

Indication

For the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 3 months of age and older.

Maralixibat (Livmarli) is used for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) who are 3 months of age and older.
A total of one systematic review/meta-analysis was reviewed, which included data from four trials involving a total of 94 patients treated with maralixibat, odevixibat or placebo.
The study found that there was a significant reduction in ItchRO scores by 1.8 points and serum bile acids by 75.8 µmol/L among ALGS patients treated with maralixibat.
In addition to reducing itchiness and serum bile acid levels, maralixibat also improved Multidimensional Fatigue Scale scores by 11.4 points and Pediatric Quality Life scale scores by 8.3 points in these patients.
However, it should be noted that alanine aminotransferase (ALT) levels were raised by an average of 40 U/L among those receiving this drug as part of their treatment regimen for ALGS-associated pruritus.
The findings suggest that while IBAT inhibitors like maralixibat show promise in treating symptoms associated with ALGS such as chronic itching and fatigue, future studies may need to focus on optimizing dosing regimens due to potential side effects including gastrointestinal issues and elevated ALT levels observed during the trials reviewed here.

Document Title	Year	Source
Livmarli (maralixibat) Prescribing Information.	2023	Mirum Pharmaceuticals Inc., Foster City, CA

Document Title	Year	Source
Ileal bile acid transporter blockers for cholestatic liver disease in pediatric patients with alagille syndrome: a systematic review and meta-analysis.	2022	Journal of Clinical Medicine