FDA Accepts sNDA for Roflumilast Cream 0.3% in Children Ages 2 to 5 with Psoriasis

The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for roflumilast (Zoryve) cream 0.3% in children aged 2-5 years with psoriasis, potentially expanding the drug’s indication.1

This November 17 announcement by Arcutis Biotherapeutics, Inc. also noted a PDUFA target action date of June 29, 2026, for roflumilast cream’s potential approval in this new age range. The medication is a once-daily, advanced targeted topical phosphodiesterase-4 (PDE4) inhibitor and saw its last expanded indication in 2023 for children aged 6-11 years with psoriasis.2

“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, Walter J. Hamlin Professor, chair of dermatology, and professor of pediatrics at Northwestern University Feinberg School of Medicine, said in a statement.1 “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.”

Psoriasis is a widespread inflammatory skin disorder that is known to impact almost 9 million individuals within the US. The skin disease is characterized by redness, pruritus, scaling, flaking, and pain. In children with psoriasis, the condition commonly involves sensitive skin and intertriginous areas, increasing psoriasis's effect on daily life among patients and families.

Roflumilast cream was described by Arcutis as the most frequently prescribed branded topical medication across seborrheic dermatitis, plaque psoriasis, and atopic dermatitis.1 The topical cream formulation works by blocking PDE4, an intracellular enzyme commonly noted as a therapeutic target in dermatology, and thereby reduces the production of pro-inflammatory signals. In doing this, roflumilast cream can result in less cutaneous inflammation and better immune balance within patients' skin.

Roflumilast cream 0.3% was shown in recent data to have demonstrated safety, tolerability, and efficacy in children aged 2-11 years with psoriasis under maximal use conditions.3 These data had shown roflumilast cream's overall safety, pharmacokinetics (PK), effectiveness, and tolerability to be consistent with previous phase 3 findings on patients aged ≥ 2 years.

Both roflumilast cream 0.3% and ZORYVE foam 0.3% have also earned the National Psoriasis Foundation’s Seal of Recognition.1 In addition, updated American Academy of Dermatology guidelines released in June 2025 include a strong recommendation for the topical cream for adults with mild to moderate atopic dermatitis.

Roflumilast cream 0.3% is currently approved by the FDA for the treatment of plaque psoriasis in adults as well as in children aged 6 and older. The latest sNDA is backed by data resulting from a 4-week Maximal Usage Systemic Exposure analysis examining children aged 2 - 5 years with psoriasis, along with data from a long-term open-label extension involving subjects in the same age bracket. Long-term findings have shown durable safety and tolerability, as well as sustained efficacy in all the ages assessed by investigators.

“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 statement.1 “If approved, [roflumilast] 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."

References

1. 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. Arcutis Biotherapeutics. https://investors.arcutis.com/news-releases/news-release-details/fda-accepts-supplemental-new-drug-application-arcutis-zoryver.

2. Smith T. FDA Grants Approval of Roflumilast Cream 0.3% for Psoriasis Patients Aged 6 to 11. HCPLive. October 6, 2023. Accessed November 17, 2025. https://www.hcplive.com/view/fda-grants-approval-roflumilast-cream-for-psoriasis-patients-aged-6-to-11.

3. Smith T. Roflumilast Cream 0.3% Effective for Psoriasis in Children Aged 2 to 11 Years. HCPLive. August 27, 2025. Accessed November 17, 2025. https://www.hcplive.com/view/roflumilast-cream-effective-psoriasis-children-aged-2-11-years.