U.S. FDA approves supplemental new drug application for expanded indication of Eucrisa (crisaborole) 2% ointment in children as young as 3 months of age with mild-to-moderate atopic dermatitis

Pfizer

24 March 2020 - Eucrisa is the first and only 100% steroid-free, topical prescription medication approved for patients as young as 3 months of age in the United States.

Pfizer announced today that the U.S. FDA has approved its supplemental new drug application for Eucrisa (crisaborole) 2% ointment, 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.

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.

Read Pfizer press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Paediatrics