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BYLVAY helped reduce any level of itch (cholestatic pruritus)
Itch can be one of the most bothersome symptoms of Alagille syndrome.
Some people live with itch so long that it feels normal, even though it’s not. For others, itch is frustrating and relentless. BYLVAY helped reduce itch whether it was mild or severe.
How itching was measured in the trial
- Less scratching meant an improvement of 1 point or more
- Little or no scratching was a score of 0 or 1 on the scale
Early and lasting reduction of itch with BYLVAY
In a clinical trial of 52 participants, BYLVAY improved caregiver-reported scratching severity as early as Week 4 and sustained over 24 weeks in participants with Alagille syndrome.
After the main study ended at 24 weeks, some participants continued treatment for longer in the extension study. Unlike the main study, both participants and researchers knew which treatment was given in the extension, and there was no placebo comparison.
By Week 24,
80% experienced less scratching with BYLVAY compared to 35% taking a placebo
54% had little or no scratching with BYLVAY compared to 18% taking placebo
Reduced itch was sustained through 48 weeks
Most common side effects
The most common side effects >5% in BYLVAY participants with Alagille syndrome were diarrhea, abdominal pain, bruising (hematoma), and decreased weight.
