Arcutis submits sNDA for roflumilast cream 0.3% for treatment of psoriasis in children 2-5 years | Image credit: Contemporary Pediatrics

Arcutis Biotherapeutics, Inc. announced the submission of a supplemental New Drug Application (sNDA) to the FDA, seeking to expand the indication for roflumilast (ZORYVE) cream 0.3% to treat plaque psoriasis in children as young as 2 years of age. If approved, roflumilast cream would be the first topical phosphodiesterase-4 (PDE4) inhibitor treatment for this patient population, according to the company.¹

“Today, there are very limited FDA-approved treatment options for plaque psoriasis for children under 6, who often present with disease on sensitive skin such as the face and intertriginous areas,” said Adelaide Hebert, MD, professor and chief of pediatric dermatology at UTHealth Houston. “There is a significant unmet need for non-steroidal options that can effectively treat plaque psoriasis over the long term. If approved, investigational ZORYVE cream could be an important first-line treatment option for children as young as age 2.”

Plaque psoriasis is the most common form of psoriasis in children, with presentations that resemble those seen in adults. In children younger than 6 years, the disease often involves sensitive sites such as the face or intertriginous areas, which increases challenges for safe and effective long-term management.¹

Roflumilast cream is a once-daily, steroid-free, non-greasy topical treatment that does not contain sensitizing excipients or irritants such as propylene glycol, polyethylene glycol, ethanol, or fragrances. The product is currently the only topical therapy specifically indicated for intertriginous psoriasis and has demonstrated efficacy, safety, and tolerability across adults and children.¹

“This submission represents another important step forward in our goal to establish ZORYVE as foundational therapy for young children suffering with inflammatory skin diseases,” said Frank Watanabe, president and CEO at Arcutis. “Historically, many treatments for inflammatory skin diseases were not studied in children, creating challenges for the clinicians who treat these vulnerable patients. Arcutis is committed to helping to address this gap in treatment through conducting trials of ZORYVE in pediatric patients across a range of inflammatory skin diseases.”

The current FDA approval of roflumilast cream 0.3%, approved on October 6, 2023, covers plaque psoriasis in adults and children aged 6 years and older. The new sNDA submission is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5 years with plaque psoriasis, along with results from a long-term open-label study. Findings from the long-term study demonstrated consistent favorable safety and tolerability as well as persistence of efficacy across pediatric age groups.

Currently, the cream formulation at 0.3% is FDA approved for plaque psoriasis in patients aged 6 years and older, while the 0.15% cream formulation is approved for mild to moderate atopic dermatitis in the same age group. Additional roflumilast formulations include roflumilast foam 0.3%, which is indicated for plaque psoriasis of the scalp and body in patients 12 years and older, and seborrheic dermatitis in patients 9 years and older. Both roflumilast cream 0.3% and foam 0.3% have received the National Psoriasis Foundation’s Seal of Recognition, the first FDA-approved therapies to earn the designation.¹

Click for more: Topical roflumilast approved indications²

• Roflumilast foam, 0.3% is approved to treat plaque psoriasis of the scalp and body in adults and pediatric patients aged 12 years and older. Click here for more on this indication, which was approved by the FDA on May 22, 2025.
• Roflumilast foam, 0.3% is approved to treat seborrheic dermatitis in adults and pediatric patients aged 9 years and older. Click here for more on this indication, which was approved by the FDA on December 15, 2025.
• Roflumilast cream, 0.3%, is approved for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. Click here for more on this indication, which was approved by the FDA on October 9, 2023.
• Roflumilast cream, 0.15%, is approved to treat mild-to-moderate AD in adult and pediatric patients aged 6 years and older. Click here for more on this indication, which was approved by the FDA on July 9, 2024.

On February 26, 2025, the FDA accepted a supplemental new drug application for roflumilast cream, 0.05%, to treat AD in children aged 2 to 5 years. With the acceptance, the federal agency granted a Prescription Drug User Fee Act date for potential FDA approval set for October 13, 2025.³

Reference:

1. Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children Ages 2 to 5. Arcutis Biotherapeutics. September 3, 2025. Accessed September 3, 2025. https://investors.arcutis.com/news-releases/news-release-details/arcutis-submits-supplemental-new-drug-application-zoryver-1
2. Fitch J. First infant enrolled in trial of roflumilast cream, 0.05% for atopic dermatitis in infants. Contemporary Pediatrics. June 10, 2025. Accessed September 3, 2025. https://www.contemporarypediatrics.com/view/first-infant-enrolled-trial-roflumilast-cream-0-05-atopic-dermatitis-infants
3. Fitch J. FDA accepts roflumilast cream 0.05% sNDA for children with atopic dermatitis. Contemporary Pediatrics. February 26, 2025. Accessed June 10, 2025. https://www.contemporarypediatrics.com/view/fda-accepts-roflumilast-cream-0-05-snda-in-children-with-atopic-dermatitis