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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."
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