FDA OKs Crisaborole for Use in Children as Young as 3 Months of Age


Crisaborole ointment, 2% (Eucrisa, Pfizer) has been approved for use in pediatric patients with atopic dermatitis as young as 3 months of age.

FDA Approval

Officials with the FDA have approved Pfizer’s supplemental New Drug Application for crisaborole (Eucrisa) ointment, 2%, for use in children as young as 3 months of age with mild-to-moderate atopic dermatitis (AD), according to a press release.

Previously, crisaborole ointment was indicated for use in adults and children 2 years of age and older. With this approval, crisaborole ointment is the only steroid-free, topical prescription medication for patients with mild-to-moderate AD who are as young as 3 months old.

Approximately 50% of pediatric patients with AD have recurrent symptoms into adolescence and adulthood, according to Pfizer. In addition to causing physical discomfort, AD can have a significant emotional and social aspect on an individual’s life.

The approval of this sNDA was based on data from a phase 4 CrisADe CARE 1 clinical study, which evaluated the safety of crisaborole ointment in infants aged 3 months to less than 24 months with mild-to-moderate AD.

In the 4-week study, crisaborole ointment, 2% was applied twice daily in 137 pediatric patients in this age group. All patients in the study had mild-to-moderate AD involving at least 5% treatable body surface area (%BSA), excluding the scalp. Additionally, a cohort of 21 patients was included in the subgroup for pharmacokinetic assessment, with clinical diagnoses of moderate AD and a minimum of 35% treatable %BSA, excluding the scalp.

Overall, the study demonstrated that crisaborole ointment, 2% was well-tolerated and effective in patients with mild-to-moderate AD, with no new safety signals identified.

“Families often spend hours each day attempting to ease their child’s eczema symptoms, affecting both infants and caregivers,” Lawrence Eichenfield, MD, chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital-San Diego, vice chair of the Department of Dermatology, and a professor Dermatology and Pediatrics at UC San Diego School of Medicine, said in a statement. “This is a struggle I see in my daily practice, and it can take a toll on the entire family. The approval of a steroid-free treatment option for this age group offers potential relief for these very young patients.”


1. US FDA Approves Supplemental New Drug application (sNDA) for Expanded Indication of Eucrisa (crisaborole) Ointment, 2%, in Children as Young as 3 Motnhs of Age with Mild-to-Moderate Atopic Dermatitis [news release]. Pfizer’s website. https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_supplemental_new_drug_application_snda_for_expanded_indication_of_eucrisa_crisaborole_ointment_2_in_children_as_young_as_3_months_of_age_with_mild_to_moderate_atopic_dermatitis. Accessed March 24, 2020

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