ZERO Spontaneous bleeds (median AsBR)
ZERO Annualized bleeds (median ABR)
ZERO Joint bleeds (median AjBR)
*FDA approved for dosing 2 to 3 times a week.
In clinical trials, the majority of bleeds successfully resolved with 1 infusion
In the remaining 6% of participants over 12 years old, bleeds were controlled with 3 or more infusions. In children under 12 years old, 3.5% of bleeds were controlled with 3 or more infusions. One child had no response.
With AFSTYLA, surgical bleeding control was rated "excellent" in 15 surgeries and "good" in 1 surgery.