FDA Accepts sNDA for ZORYVE Cream 0.3% in Children Aged 2 to 5

Key Takeaways

• The FDA has accepted sNDA for ZORYVE (roflumilast cream 0.3%) to treat plaque psoriasis in children aged 2 to 5 years.

• Approval would make roflumilast the first and only topical PDE4 inhibitor approved for this age group, according to Arcutis Biotherapeutics.

• Data from MUSE and long-term studies showed safety, tolerability, and efficacy. 

The US Food and Drug Administration (FDA) has accepted Arcutis Biotherapeutics’ supplemental New Drug Application (sNDA) seeking an expanded indication for ZORYVE® (roflumilast) cream 0.3% to include children ages 2 to 5 with plaque psoriasis.

The sNDA is supported by data from a four-week Maximal Usage Systemic Exposure (MUSE) study in children ages 2 to 5, as well as a long-term open-label study including this age group. In the trial program, roflumilasta demonstrated favorable long-term safety, tolerability, and sustained efficacy. Currently approved for adults and children 6 years and older with plaque psoriasis, it would become the first and only topical PDE4 inhibitor indicated for this age group, if approved.

“Plaque psoriasis in young children can be particularly challenging to manage, as it often affects sensitive areas such as the face and intertriginous skin,” said Amy Paller, MS, MD, chair of dermatology at Northwestern University Feinberg School of Medicine. "Effective and well-tolerated treatment options that are gentle enough for these areas are critical to support long-term disease control and improve quality of life for children and their families.”

The agency assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026.

Source: Arcutis press release, November 17, 2025.