Drug updated on 9/4/2024
Dosage Form | Oral solution (oral; 9.5 mg/mL) |
Drug Class | Ileal bile acid transporter inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of cholestatic pruritus in patients 3 months of age and older with Alagille syndrome (ALGS).
- Indicated for the treatment of cholestatic pruritus in patients 5 years of age and older with progressive familial intrahepatic cholestasis (PFIC).
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Summary
- Livmarli (maralixibat) is indicated for the treatment of cholestatic pruritus in patients 3 months of age and older with Alagille syndrome (ALGS) and for the treatment of cholestatic pruritus in patients 5 years of age and older with progressive familial intrahepatic cholestasis (PFIC).
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Maralixibat was effective in reducing ItchRO scores by 1.8 points and serum bile acids (sBAs) by 75.8 µmol/L in patients with Alagille syndrome (ALGS).
- Patients receiving maralixibat experienced an improvement of 11.4 points on the Multidimensional Fatigue Scale and an 8.3-point improvement on the Pediatric Quality of Life (QL) Scale.
- The study did not provide specific comparative effectiveness data between maralixibat and odevixibat or detailed effectiveness outcomes across different population subgroups.
- Maralixibat was associated with an increase in ALT levels by 40 U/L, suggesting a potential safety concern related to liver function in patients with Alagille syndrome (ALGS).
- There is no comparative safety data available between maralixibat and odevixibat in the provided study, and future trials should consider gastrointestinal side effects and drug-induced ALT elevation in ALGS patients.
- The study focuses on patients with Alagille syndrome (ALGS), with findings such as reductions in ItchRO scores, sBAs, improvements in the Multidimensional Fatigue Scale, and Pediatric QL scale, being clinically relevant for this specific population. Additionally, the increase in ALT levels emphasizes the need for vigilant liver function monitoring in ALGS patients.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Livmarli (maralixibat) Prescribing Information. | 2024 | 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 |