Eucrisa approved for AD use in infants aged 3 months and older

April 1, 2020

The US Food and Drug Administration has given approval for a supplemental new drug application for Eucrisa (crisaborole) that allows the nonsteroidal topical ointment to be used for treating mild-to-moderate atopic dermatitis (AD) in children aged as young as 3 months.

Pediatricians have a new way to tackle mild-to-moderate atopic dermatitis (AD) in infants with the US Food and Drug Administration’s approval of a supplemental new drug application for Pfizer’s Eucrisa (crisaborole) 2% ointment.1 The drug had previously been approved for use in children aged 2 years and older.

The approval was based on the CrisADe CARE 1 Study, which was a Phase 4 trial. The trial was a 4-week, multicenter, open-label, single-arm study that looked at the safety of applying crisaborole 2% ointment twice a day. There were 137 pediatric patients aged 3 months to younger than 24 months who had mild-to-moderate AD that involved at least 5% of the body surface area, excluding the scalp. A pharmacokinetic assessment was performed on a subset of 21 children who had a diagnosis of moderate AD that affected at least 35% of the body surface area. The study found that the drug was well tolerated and effective with no difference in safety outcome in comparison with previous research.

In a press release for the supplemental approval, Lawrence Eichenfield, MD, chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital-San Diego, California, vice chair of the Department of Dermatology, and professor of Dermatology and Pediatrics at the University of California-San Diego School of Medicine, said "Families often spend hours each day attempting to ease their child’s eczema symptoms, affecting both infants and caregivers. The approval of a steroid-free treatment option for this age group offers potential relief for these very young patients."

References:

1. Pfizer. US 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 [press release]. Published March 24, 2020. Accessed March 31, 2020. 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