FDA Accepts sNDA for Roflumilast Cream 0.3% to Treat Plaque Psoriasis in Children Aged 2 to 5 Years

The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for roflumilast cream 0.3% (ZORYVE^®, Arcutis Biotherapeutics) to expand its indication to include children aged 2 to 5 years with plaque psoriasis, according to a company announcement. The agency set a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026.

If approved, roflumilast cream 0.3% would become the first topical phosphodiesterase-4 (PDE4) inhibitor indicated for plaque psoriasis in children as young as 2 years.

Clinical Need in Pediatric Psoriasis

Plaque psoriasis in young children often affects thin-skinned and intertriginous areas, posing challenges for long-term management. “Plaque psoriasis in young children can be particularly challenging to manage, as it often affects sensitive areas such as the face and intertriginous skin,” Amy Paller, MS, MD, sain in the press release. “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.”

Roflumilast cream 0.3% is currently approved for plaque psoriasis in adults and children aged ≥6 years.

Evidence Supporting the sNDA

The sNDA is supported by findings from:

• A 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5 years with plaque psoriasis.
• A long-term open-label study that included participants in this age group and demonstrated favorable long-term safety, tolerability, and persistence of efficacy across all ages studied.

Roflumilast is an advanced targeted topical PDE4 inhibitor that reduces pro-inflammatory signaling in the skin. The cream formulation is the most prescribed branded topical therapy across atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, according to Arcutis.

“This milestone brings us closer to helping families and clinicians caring for young children with plaque psoriasis,” Frank Watanabe, president and CEO of Arcutis, said in a press release. “If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for children as young as two, offering a steroid-free option that delivers both efficacy and tolerability for this particularly vulnerable group.”

Reference: FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5. News release. Arcutis. November 17, 2025. Accessed November 17, 2025. https://www.globenewswire.com/news-release/2025/11/17/3189050/0/en/FDA-Accepts-Supplemental-New-Drug-Application-for-Arcutis-ZORYVE-roflumilast-Cream-0-3-for-the-Treatment-of-Plaque-Psoriasis-in-Children-Ages-2-to-5.html