ZORYVE (roflumilast) Cream 0.05% - (INTEGUMENT-INFANT)

July 8, 2026: Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) announced the FDA accepted its supplemental NDA for ZORYVE (roflumilast) cream 0.05% to expand the indication for topical treatment of mild to moderate atopic dermatitis to infants aged 3 to 24 months. The FDA set a PDUFA target action date of February 23, 2027.

The sNDA is supported by positive results from the Phase 2 open-label INTEGUMENT-INFANT study (n=101; 4-week safety/tolerability and exploratory efficacy) and a Phase 1 open-label pharmacokinetic study (n=19) in infants 3 months to <24 months, using once-daily ZORYVE cream 0.05%. Through 4 weeks, studies reported no new safety signals; commonly reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting.

In INTEGUMENT-INFANT completers at Week 4 (n=96), 34.4% achieved vIGA-AD success (clear/almost clear with ≥2-grade improvement) and 58.3% achieved EASI-75 at Week 4 (34% at Week 2). Among those with baseline scalp involvement, 67.5% (27/40) achieved vIGA-scalp success at Week 4. Caregiver-assessed itch improved rapidly, with 46.6% achieving DPS-25 within 10 minutes post-application (n=88).