Arcutis Biotherapeutics (ARQT) said Wednesday that the FDA accepted its application to expand ZORYVE cream 0.05% for infants with mild-to-moderate atopic dermatitis and has set a PDUFA action date of Feb. 23.
The filing seeks approval for infants aged 3 to 24 months, it said.
Arcutis said Phase 2 and Phase 1 studies showed the once-daily, steroid-free treatment was well tolerated. The studies also showed improvements in eczema symptoms and itch, it added.
ZORYVE is currently approved for children aged 2 to 5 years, Arcutis said.
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