FDA approves Zoryve cream for psoriasis in younger children

FDA approved Zoryve (roflumilast) cream 0.3% for topical treatment of plaque psoriasis, including intertriginous areas, in children as young as two years. The PDE4 inhibitor was previously approved for plaque psoriasis in adults and children aged six years and older.

The expanded indication addresses a practical treatment gap in pediatric psoriasis. Young children can have plaques on sensitive areas such as the face, genitals, and skin folds, where topical corticosteroids are often used cautiously because of concerns with long-term continuous use or use on thin skin.

Zoryve cream is a once-daily, steroid-free topical that can be used anywhere on the body and has no restriction on duration of use. That may make it useful for children with chronic plaque psoriasis who need repeated or ongoing topical treatment, including in intertriginous areas.

The approval was based on a four-week maximal usage systemic exposure study evaluating Zoryve cream 0.3% in children aged two to five years with plaque psoriasis involving at least 2% body surface area. The open-label study assessed pharmacokinetics, safety, tolerability, and exploratory efficacy. Supportive long-term safety data came from an open-label extension study in children aged two to five years for up to 24 weeks of treatment.

Arcutis said the safety profile and exploratory efficacy findings in young children were generally consistent with results observed in the DERMIS-1 and DERMIS-2 phase 3 trials in adolescents and adults.

Safety considerations include avoiding Zoryve in patients with moderate to severe liver impairment, defined as Child-Pugh B or C. The most common adverse reactions reported in plaque psoriasis studies of Zoryve cream 0.3% were diarrhea, headache, insomnia, nausea, application-site pain, upper respiratory tract infection, and urinary tract infection.

“Young children with plaque psoriasis face unique challenges, including disease involvement on sensitive skin, such as the face and skin folds,” said Lisa Swanson, MD, FAAD, board-certified pediatric dermatologist and clinical trial investigator at Ada West Dermatology. “Although topical steroids are commonly used to treat pediatric plaque psoriasis, they are not recommended on sensitive areas or for long-term, continuous use. 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 Biotherapeutics. (2026 June 29). FDA approves Arcutis’ Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children as young as age 2