Arcutis submits FDA application to expand ZORYVE cream for infants
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Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months
April 27, 2026 8:00 AM EDTSubmission supported by data from INTEGUMENT-INFANT Phase 2 open-label study in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitisOnce-daily ZORYVE cream was well tolerated with a safety profile consistent with that in older children and adultsAtopic dermatitis impacts 1 million children under the age of 2 in the United StatesOnly one other FDA-approved topical non-steroidal anti-inflammatory agent available for this vulnerable population
WESTLAKE VILLAGE, Calif., April 27, 2026 (GLOBE NEWSWIRE) --... More
