ZORYVE (roflumilast) Cream 0.3%

June 29, 2026: Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) announced FDA approval of a supplemental NDA expanding ZORYVE (roflumilast) cream 0.3% for topical treatment of plaque psoriasis, including intertriginous areas, to pediatric patients down to age 2 (previously approved down to age 6). The company says this makes ZORYVE cream 0.3% the first once-daily, non-steroidal therapy approved for children as young as 2 with plaque psoriasis, and suitable for use anywhere on the body without duration-of-use restrictions.

The expanded indication was supported by a 4-week open-label Maximal Usage Systemic Exposure (MUSE) study (ARQ-151-216) in children ages 2–5 with ≥2% body surface area involvement, assessing pharmacokinetics, safety/tolerability, and exploratory efficacy, plus supportive long-term data from an open-label extension (ARQ-151-306) evaluating up to 24 weeks of treatment in ages 2–5. Arcutis stated safety and efficacy were generally consistent with prior DERMIS-1 and DERMIS-2 pivotal Phase 3 trials in adolescents and adults.

Arcutis also noted this is the seventh FDA approval for ZORYVE in four years and that ZORYVE cream 0.3% is available via wholesaler and dermatology pharmacy channels.