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.
Summary
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Livmarli (maralixibat) Prescribing Information. | 2023 | Mirum Pharmaceuticals Inc., Foster City, CA |
Systematic Reviews / Meta-Analyses
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 |