The FDA has expanded the indication for odevixibat to include treatment of cholestatic pruritus associated with Alagille syndrome in patients as young as 12 months.
The study also met the key secondary endpoint showing a highly statistically significant reduction in serum bile acid concentration from baseline to the average of weeks 20 and 24, compared with placebo .
The overall incidence of treatment-emergent adverse events was similar to placebo. No patients left the study, and 96% of patients rolled over into the open-label extension study., abdominal pain, hematoma, and weight loss.
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