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news.Arcutis Biotherapeutics has launched Zoryve (roflumilast) cream at a concentration of 0.05% for the treatment of mild to moderate atopic dermatitis in children aged between two and five years in the US.
Clinical trials show that roflumilast cream 0.05% significantly alleviates atopic dermatitis symptoms. Credit: Arcutis.
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This topical, steroid-free formulation is applied once daily and can be used for long-term disease control without limits on duration or body surface area.
Clinical trials have shown that the cream significantly alleviates the symptoms and signs of atopic dermatitis, including a notable reduction in itch.
The expanded label now permits its use in young children, thereby enhancing the Zoryve portfolio to encompass a wider paediatric demographic.
Arcutis chief commercial officer Todd Edwards said: “Atopic dermatitis is one of the most common chronic skin conditions in young children, yet safe and effective long-term treatment options have been limited, especially for children ages two to five.
“With Zoryve cream 0.05%, families have a once-daily, steroid-free, and well-tolerated treatment that targets the underlying inflammation of atopic dermatitis.
“Zoryve provides a foundation for ongoing control, and can be used for any duration, anywhere on the body, with no restrictions on body surface area. We are excited to make this important treatment widely available to help improve outcomes for children and their families.”
The product is scheduled to be available in pharmacies and this week and is currently undergoing evaluation by pharmacy benefit managers and health plans to ensure coverage is consistent with other Zoryve products.
Arcutis will continue its Zoryve direct programme, which assists eligible patients in minimising out-of-pocket expenses, accessing their prescribed medication.
Additionally, financially eligible uninsured or underinsured patients can benefit from support through the Arcutis Cares patient assistance programme.
Arcutis announced that the US Food and Drug Administration (FDA) granted approval for this indication on 6 October 2025.
