Pfizer Inc announced that the FDA has approved its supplemental New Drug Application (sNDA) for Eucrisa (crisaborole) ointment, 2%, extending the lower age limit from 24 months down to 3 months in children with mild-to-moderate atopic dermatitis (AD), also known as eczema. Eucrisa was previously approved for use in adults and children 2 years of age and older.
This supplemental approval makes Eucrisa the first and only steroid-free, topical prescription medication for mild-to-moderate AD patients as young as 3 months of age.
The approval for the expanded indication of Eucrisa was supported by data from a Phase IV, open-label, clinical study designed to assess the safety of crisaborole ointment in infants aged 3 months to less than 24 months with mild-to-moderate AD, with effectiveness as an exploratory endpoint. In this study, crisaborole ointment, 2%, was well-tolerated and demonstrated effectiveness in patients with mild-to-moderate AD with no new safety signals identified.