Following a supplemental new drug application (sNDA), the U.S. Food and Drug Administration (FDA) has granted approval for ZORYVE® (roflumilast) cream 0.05%, which is indicated for the topical treatment of mild to moderate atopic dermatitis in young children aged 2 to 5 years, as announced by Arcutis Biotherapeutics, Inc.

This latest approval, the sixth for the ZORYVE portfolio in just over three years, addresses a critical unmet need for the approximately 1.8 million children in this age group who are topically treated for the condition in the U.S. ZORYVE 0.05% is a once-daily, steroid-free cream that can be used on any body area for any duration, offering a significant and safer alternative to traditional topical steroids which are not suitable for long-term use.

Clinically, ZORYVE demonstrated rapid efficacy, with trials showing swift improvement in the severity and extent of eczema, including a clinically meaningful improvement in itch intensity in over one-third of children within four weeks.

The medication is an advanced topical phosphodiesterase 4 (PDE4) inhibitor that targets the underlying inflammation driving the disease without using ingredients known to compromise the skin barrier—a critical consideration for young children whose immune systems and skin barriers are less developed.

This disease profoundly impacts the entire family through sleep disruption and emotional distress, making effective, long-term treatments highly desired by caregivers. Arcutis expects the commercial product to be available by the end of October 2025, supported by the ZORYVE® Direct Program and the Arcutis Cares™ patient assistance program to ensure accessible and predictable delivery for eligible patients.