FDA Expands Use of Zoryve to Include Young Children With Plaque Psoriasis

TUESDAY, July 14, 2026 (HealthDay News) — The U.S. Food and Drug Administration has approved an expanded indication for Zoryve (roflumilast) cream 0.3 percent for the topical treatment of plaque psoriasis in patients ages 2 years and older.

Zoryve is a once-daily, steroid-free topical cream that is suitable for use anywhere on the body with no limitations on duration of use.

The approval is based on data from a four-week Maximal Usage Systemic Exposure study evaluating Zoryve cream 0.3 percent in children ages 2 to 5 years with plaque psoriasis involving at least 2 percent of body surface area. Both the open-label study, which assessed pharmacokinetics, safety, tolerability, and exploratory efficacy in children, and supportive long-term safety data derived from an open-label extension study for up to 24 weeks of treatment showed safety and efficacy profiles that were generally consistent with those observed in the DERMIS-1 and DERMIS-2 pivotal phase 3 trials in adolescents and adults.

“Young children with plaque psoriasis face unique challenges, including disease involvement on sensitive skin, such as the face and skin folds,” Lisa Swanson, M.D., a clinical trial investigator, said in a statement. “Although topical steroids are commonly used to treat pediatric plaque psoriasis, they are not recommended on sensitive areas or for long-term, continuous use.”

The expanded approval of Zoryve was granted to Arcutis Biotherapeutics.

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