Odevixibat

(Bylavy®)

Odevixibat

Drug updated on 5/17/2024

Dosage FormPellet (oral; 200 mcg, 600 mcg); Capsule (oral; 400 mcg, 1200 mcg)
Drug ClassIleal 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
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  • 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 ┬Ámol/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 TitleYearSource
Bylavy (odevixibat) Prescribing Information.2021Albireo Pharma Inc., Boston, MA

Systematic Reviews / Meta-Analyses