The U.S. Food and Drug Administration (FDA) gave its nod to Pfizer’s Eucrisa ointment, 2%, for children as young as age 3 months with mild-to-moderate atopic dermatitis (AD).

Eucrisa was previously approved for use in adults and children 2 years of age and older. It is the first and only steroid-free, topical prescription medication for mild-to-moderate AD patients as young as 3 months of age.

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

 “Despite atopic dermatitis often manifesting during infancy, there are few approved treatment options for this population available today,” adds Richard Blackburn, Global President, Inflammation & Immunology, Pfizer. “We are committed to making a meaningful difference to patients’ lives, and with this indication extension, we look forward to now helping many of the youngest children suffering with eczema.”

The approval for the expanded indication of EUCRISA was supported by data from a Phase 4, 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.

About the CrisADe CARE 1 Study

The supplemental New Drug Application submission was based on data from the Phase 4 CrisADe CARE 1 trial. The four-week, multicenter, open-label, single-arm study evaluated the safety of crisaborole ointment, 2%, applied twice daily in 137 pediatric patients who were 3 months to less than 24 months of age, with effectiveness as an exploratory endpoint. All patients had mild-to-moderate AD involving at least 5% treatable body surface area (%BSA), excluding the scalp. A cohort of 21 of the 137 subjects was included in a subgroup for pharmacokinetic (PK) assessment, with clinical diagnoses of moderate AD and a minimum of 35% treatable %BSA, excluding the scalp.