Wednesday, Arcutis Biotherapeutics, Inc. (ARQT) announced the U.S. Food and Drug Administration has accepted its supplemental New Drug Application for ZORYVE cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months.
The FDA has set a PDUFA target action date of February 23, 2027.
The application is backed by positive results from the Phase 2 open-label INTEGUMENT-INFANT study, as well as a Phase 1 open-label pharmacokinetic study. Both studies showed that PK, safety, and efficacy profiles over 4 weeks were consistent with those from prior atopic dermatitis studies in children 2 to 5 years of age treated with ZORYVE cream 0.05%.
If approved, the once-daily, steroid-free, non-greasy topical treatment could provide clinicians and caregivers with an important new steroid-free treatment option that was specifically developed for infants and very young children.
In the pre-market hours, ARQT is trading at $27.77, up 0.36 percent on the Nasdaq.
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