Drug updated on 3/28/2024
| 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
- For the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).
Summary
- Odevixibat (Bylavy) is used for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).
- A total of one systematic review/meta-analysis document was reviewed, which included data from four trials involving odevixibat.
- The study population consisted mainly of Alagille syndrome (ALGS) patients who suffer from refractory pruritus due to chronic cholestasis.
- Compared to a placebo, odevixibat significantly reduced ItchRO scores by 1.8 points and serum bile acids by 75.8 µmol/L in ALGS patients.
- Additionally, multidimensional fatigue scale scores improved by 11.4 points and pediatric quality life scale increased by 8.3 points after using odevixibat.
- However, it should be noted that alanine aminotransferase levels were raised by 40 U/L during the use of this drug indicating potential liver damage or inflammation as an adverse effect associated with its usage.
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 |
|---|---|---|
| Odevixibat for treating progressive familial intrahepatic cholestasis. | 2022 | NICE |
| 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 |
| Assessment report: Bylvay. | 2021 | EMA |