The U.S. Food and Drug Administration (FDA) has expanded the approval of Zoryve (roflumilast) cream 0.3%, allowing its use for the treatment of plaque psoriasis in children aged two years and older.

The once-daily, steroid-free topical cream can be applied to any part of the body, including sensitive areas, without restrictions on the duration of treatment, offering a new long-term treatment option for young children living with plaque psoriasis.

The expanded approval is based on results from a four-week Maximal Usage Systemic Exposure study involving children aged 2 to 5 years with plaque psoriasis affecting at least 2% of their body surface area.

Researchers evaluated how the medicine was absorbed by the body, along with its safety, tolerability and effectiveness. The findings, supported by long-term safety data from an extension study that followed patients for up to 24 weeks, showed that the cream had a safety and efficacy profile consistent with results previously seen in the phase 3 DERMIS-1 and DERMIS-2 clinical trials involving adolescents and adults.

Dr. Lisa Swanson, a clinical trial investigator, said young children with plaque psoriasis often develop lesions on sensitive areas such as the face and skin folds, making treatment more challenging. She noted that while topical corticosteroids are commonly prescribed for pediatric psoriasis, they are generally not recommended for prolonged use or for continuous application on delicate skin.

The expanded approval provides clinicians with a steroid-free alternative that may help address these limitations while offering long-term disease management.

Plaque psoriasis is a chronic inflammatory skin disease that causes thick, scaly, itchy patches on the skin and can significantly affect quality of life, even in young children.

The expanded indication for Zoryve cream was granted to Arcutis Biotherapeutics, which developed the topical therapy.