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

Submission 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 dermatitis Once-daily ZORYVE cream was well tolerated with a safety profile consistent with that in older children and adults Atopic dermatitis impacts 1 million children under the age of 2 in the United States Only one other FDA-approved topical non-steroidal anti-inflammatory agent available for this vulnerable population WESTLAKE VILLAGE, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication for ZORYVE® (roflumilast) cream 0.05% to include the topical treatment of mild to moderate atopic dermatitis in infants down to 3 months.