FDA Expands ZORYVE Cream Approval to Children as Young as 2 Years With Plaque Psoriasis

The US Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics' supplemental New Drug Application (sNDA) expanding the indication for ZORYVE (roflumilast) cream 0.3% to include the topical treatment of plaque psoriasis, including intertriginous areas, in children as young as 2 years. 

Pediatric Plaque Psoriasis Treatment Options Expand

The approval extends the previous pediatric indication from age 6 years to age 2 years and marks the seventh FDA approval across the ZORYVE franchise in four years. According to Arcutis, ZORYVE cream 0.3% is the first once-daily, steroid-free topical therapy approved for plaque psoriasis in children aged 2 years and older and is indicated for use anywhere on the body without limitations on duration of therapy.

The expanded indication is supported by results from the open-label Maximal Usage Systemic Exposure (MUSE) study, which evaluated pharmacokinetics, safety, tolerability, and exploratory efficacy in children aged 2 to 5 years with plaque psoriasis involving at least 2% body surface area. Additional long-term safety data were obtained from the ARQ-151-306 extension study, which followed patients for up to 24 weeks. Investigators reported that safety and efficacy findings were generally consistent with those observed in the pivotal Phase 3 DERMIS-1 and DERMIS-2 trials conducted in adolescents and adults.

"Youth with plaque psoriasis have unique treatment challenges, particularly when disease affects sensitive skin," Lisa Swanson, MD, FAAD, a pediatric dermatologist and clinical trial investigator, said in the company announcement. "This approval provides physicians and caregivers a targeted topical therapy that can be used anywhere on the body for any duration of time."

Source

Arcutis press release. June 29, 2026.