Drug updated on 5/17/2024
Dosage Form | Pellet (oral; 200 mcg, 600 mcg); Capsule (oral; 400 mcg, 1200 mcg) |
Drug Class | Ileal bile acid transporter inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).
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Summary
- Odevixibat (Bylavy) is indicated for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC) as well as its application in Alagille syndrome (ALGS), characterized by refractory pruritus due to chronic cholestasis.
- Information was derived from a single systematic review/meta-analysis study focusing on Bylavy's effectiveness and safety profile.
- In comparison to other drugs such as maralixibat and placebo, odevixibat demonstrated a significant reduction in Itch Scale Scores by 1.8 points and Serum Bile Acids by 75.8 µmol/L, indicating efficacy in managing cholestasis. There were also improvements on the Multidimensional Fatigue Scale and Pediatric Quality of Life scale scores, suggesting an overall enhancement in quality of life.
- However, there was an observed increase in alanine aminotransferase levels by 40 U/L, indicating potential liver enzyme elevation, which presents a safety concern that needs careful monitoring during treatment.
- The study specifically focused on patients with Alagille syndrome within the larger demographic indicated for Bylavy; however, no specific details were given regarding age subgroups or gender considerations beyond this condition being studied.
- Despite showing considerable effectiveness against pruritus associated with ALGS and improving quality-of-life indicators based on patient-reported outcomes related to fatigue management, among others, further research into diverse population subgroups alongside long-term outcomes will be crucial for fully establishing comparative effectiveness versus other therapeutic options, considering drug-induced ALT level elevations necessitating further attention, especially when optimizing dosing regimens.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Bylavy (odevixibat) Prescribing Information. | 2021 | Albireo Pharma Inc., Boston, MA |
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 |