- A pooled analysis of phase 3 data showed that odevixibat was associated with increased mean levels of serum ALTs in patients with Alagille syndrome.
- Despite the increase in ALT levels, there were no concurrent increases in total bilirubin, and patients showed significant improvements in pruritus outcomes.
- Patients receiving odevixibat experienced increases in ALT and GGT levels initially, which generally plateaued or decreased by week 48. Total bilirubin levels remained relatively stable.
- A small number of patients receiving Odevixibat reported potentially clinically significant elevations in AST and/or ALT levels, but drug-induced liver injury was deemed unlikely based on clinical information.
- Patients treated with Odevixibat showed substantial improvements in pruritus regardless of ALT changes.