California-based Arcutis Biotherapeutics (Nasdaq: ARQT) has received US FDA approval to expand the indication for Zoryve (roflumilast) cream 0.3% to children as young as age 2 with plaque psoriasis — making it the first once-daily, non-steroidal topical therapy approved for this age group. The decision, based on a supplemental New Drug Application, extends a label that previously covered adults and children from age 6, and represents the seventh FDA approval for the Zoryve portfolio in four years.
The approval addresses a longstanding clinical gap in pediatric dermatology. Topical corticosteroids, the most commonly used agents in this population, carry label restrictions against prolonged use on sensitive or intertriginous skin — the face, groin, and skin folds where psoriasis frequently presents in young children. Zoryve cream 0.3% carries no restrictions on body site or duration of use, which distinguishes it from steroid-based alternatives in this setting.
Roflumilast selectively inhibits phosphodiesterase type 4 (PDE4), an intracellular enzyme that, when active, sustains production of pro-inflammatory mediators. Topical inhibition reduces cutaneous inflammation without the systemic immunosuppression or skin-atrophy risk associated with corticosteroids. The molecule was originally developed for respiratory indications before Arcutis licensed exclusive topical dermatology rights from AstraZeneca in 2018.
The expanded label rests on data from study ARQ-151-216, a 4-week open-label Maximal Usage Systemic Exposure (MUSE) study in children ages 2 to 5 with plaque psoriasis involving at least 2% body surface area, assessing pharmacokinetics, safety, tolerability, and exploratory efficacy. Long-term supportive data came from open-label extension study ARQ-151-306, which followed the same age group for up to 24 weeks. Safety and efficacy profiles were reported as broadly consistent with those from the DERMIS-1 and DERMIS-2 pivotal Phase III trials conducted in adolescents and adults.