Odevixibat

(Bylvay®)

Bylvay®

Drug updated on 10/25/2024

Dosage Form Pellets (oral; 200 mcg, 600 mcg) Capsule (oral; 400 mcg, 1200 mcg)
Drug ClassIleal bile acid transporter (IBAT) 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)
  • Indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with Alagille syndrome (ALGS).

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Summary
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  • This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
  • Odevixibat (Bylvay) significantly reduced itch scores by 1.8 points on the ItchRO scale and decreased serum bile acids by 75.8 µmol/L in patients with Alagille syndrome (ALGS). Additionally, pediatric quality of life scores improved by 8.3 points, and fatigue, measured by the Multidimensional Fatigue Scale, improved by 11.4 points.
  • Both odevixibat and maralixibat demonstrated effectiveness in reducing pruritus and serum bile acids in ALGS patients. However, no specific comparative figures between these two drugs were detailed in the study. The findings focus on improvements in quality of life, itch, and biochemical markers for the ALGS population.
  • Odevixibat (Bylvay) treatment was associated with an increase in alanine aminotransferase (ALT) levels by 40 U/L, indicating potential liver stress or damage, requiring close monitoring in patients.
  • Gastrointestinal side effects were noted, although specific details on their frequency or nature were not provided, suggesting a need for future trials to evaluate their impact on treatment and dosing regimens.
  • The study population consisted of patients with Alagille syndrome (ALGS), a rare genetic condition characterized by chronic cholestasis and refractory pruritus. No specific population subgroups (e.g., age groups, gender, or comorbidities) were reported, and findings on effectiveness and safety apply generally to the entire ALGS patient population studied.

Product Monograph / Prescribing Information

Document TitleYearSource
Bylvay (odevixibat) Prescribing Information.2024Ipsen Biopharmaceuticals, Inc., Cambridge, MA

Systematic Reviews / Meta-Analyses