Drug updated on 9/4/2024
| 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
- Bylavy (odevixibat) is indicated for the treatment of pruritus in patients 3 months 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]
- ItchRO Scores: There was a significant reduction of 1.8 points in patients with Alagille syndrome (ALGS), reflecting decreased pruritus severity.
- Serum Bile Acids (sBAs): A significant reduction of 75.8 μmol/L was observed, indicating effective lowering of bile acids in ALGS patients.
- Multidimensional Fatigue Scale: Improvement by 11.4 points, signifying reduced fatigue in ALGS patients.
- There was a significant increase in ALT levels by 40 U/L, noted as a safety concern.
- Gastrointestinal side effects were indicated as a significant concern, but specific data were not provided.
- There is no population type or subgroup information available in the reviewed studies.
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 |