USFDA approves Pfizer supplemental New Drug Application for EUCRISA (crisaborole) ointment for children with eczema

US: Pfizer Inc. has announced that the U.S. Food and Drug Administration (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.

"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," said 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. "The approval of a steroid-free treatment option for this age group offers potential relief for these very young patients."

AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects that affects nearly 18 million people and approximately 11% of children in the U.S. Early-onset AD is the most common form of the condition and begins within the first two years of life. A total of 45% of all AD cases begin within the first six months of life, and 60% begin during the first year.

"Despite atopic dermatitis often manifesting during infancy, there are few approved treatment options for this population available today," said 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 from 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.

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