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BYLVAY helped reduce any level of itch (pruritus)
Itch can be one of the most bothersome symptoms of progressive familial intrahepatic cholestasis (PFIC).
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 62 participants, BYLVAY improved caregiver-reported scratching severity as early as Week 4 and sustained over 24 weeks in participants with PFIC.
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.
Over 24 weeks, little or no scratching was achieved by:
- 35% of participants taking BYLVAY 40 mcg/kg/day
- 30% of participants taking BYLVAY 120 mcg/kg/day
- 13% of participants taking placebo
By 48 weeks,*
of BYLVAY participants achieved little or no scratching
Over 24 weeks, less scratching was experienced by:
- 52% of participants taking BYLVAY 40 mcg/kg/day
- 32% of participants taking BYLVAY 120 mcg/kg/day
- 11% of participants taking placebo
By 48 weeks,*
of BYLVAY participants achieved less scratching
Reduced itch was sustained through 96 weeks
*In the extension trial, all 112 enrolled participants received 120 mcg/kg/
day of BYLVAY.