This site is intended for healthcare professionals

FDA approves expanded indication of Eucrisa ointment, 2%, in children as young as 3 months of age with mild-to-moderate atopic dermatitis.- Pfizer

Read time: 1 mins
Published:25th Mar 2020
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.
Condition: Atopic Dermatitis (Eczema)
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.