FDA Approves Roflumilast Cream 0.3% for Plaque Psoriasis in Children as Young as 2 Years

On June 29, 2026, the US Food and Drug Administration (FDA) approved a supplemental New Drug Application for roflumilast cream 0.3%, expanding its indication for the topical treatment of plaque psoriasis, including intertriginous areas, in children aged 2 years and older. The approval makes roflumilast cream 0.3% the first once-daily, nonsteroidal topical therapy approved for plaque psoriasis in children as young as 2 years of age.

“Young children with plaque psoriasis face unique challenges, including disease involvement on sensitive skin, such as the face and skin folds. Although topical steroids are commonly used to treat pediatric plaque psoriasis, they are not recommended on sensitive areas or for long-term, continuous use,” said Lisa Swanson, MD, FAAD, board-certified pediatric dermatologist and clinical trial investigator at Ada West Dermatology. “In clinical studies, roflumilast cream 0.3% demonstrated consistent safety and efficacy in improving the signs and symptoms of plaque psoriasis as seen in adults and adolescents and was safe and well tolerated in children as young as age 2. This approval provides physicians and caregivers with a targeted topical therapy that can be used anywhere on the body for any duration of time.”

The FDA approval is based on data from the 4-week Maximal Usage Systemic Exposure (MUSE) study (ARQ-151-216), which evaluated roflumilast cream 0.3% in children aged 2 to 5 years with plaque psoriasis involving at least 2% body surface area. The open-label study assessed pharmacokinetics, safety, tolerability, and exploratory efficacy. Additional long-term safety data were provided by the ARQ-151-306 open-label extension study, which evaluated treatment for up to 24 weeks.

The studies demonstrated:

• Safety and efficacy profiles that were generally consistent with those observed in the pivotal DERMIS-1 and DERMIS-2 phase 3 trials in adolescents and adults
• Roflumilast cream 0.3% was safe and well tolerated in children aged 2 to 5 years
• The therapy may be used once daily, anywhere on the body, including intertriginous areas, with no limitations on duration of use

“Parents and caregivers of young children with plaque psoriasis have faced a significant treatment gap for years, with very limited options, even though this skin condition can have a profound impact on the child and the entire family,” said Leah Howard, president and chief executive officer of the National Psoriasis Foundation. “The FDA approval of a once-daily, steroid-free topical treatment for children as young as 2 introduces an important new treatment option for a largely overlooked population and represents a significant advancement in pediatric psoriasis care.”

Reference

FDA approves Arcutis’ ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children as young as age 2. Arcutis. Press release. June 29, 2026. Accessed June 30, 2026. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-3-for-the-treatment-of-plaque-psoriasis-in-children-as-young-as-age-2