FDA Accepts Supplemental New Drug Application for Arcutis’ Roflumilast in Children with AD

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The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Arcutis Biotherapeutics’ roflumilast (Zoryve) cream 0.05% to treat children aged 2 to 5 with mild to moderate atopic dermatitis (AD).¹ The application is supported by promising data from pivotal phase 3 trials, long-term extension studies, and pharmacokinetic research, including results from the INTEGUMENT-PED phase 3 clinical trial announced earlier this week.²

“In clinical trials, investigational ZORYVE cream 0.05% has shown significant positive results in treating AD in children 2 to 5 years old. The data highlight the efficacy of the cream, along with its favorable safety and tolerability profile, which are critical when prescribing a long-term treatment for children with AD,” said Mercedes E. Gonzalez, MD, medical director of Pediatric Skin Research, LLC, and INTEGUMENT PED clinical trial investigator. “In children, AD often occurs on sensitive areas like the face and neck. In addition to persistent itching and scratching, AD is associated with a lower quality of life for the affected child and caregiver. If approved, ZORYVE cream 0.05% will provide a new treatment option that offers long-term relief and can help alleviate the disease burden for children and their caregivers.”¹

The INTEGUMENT-PED phase 3 trial involved 652 children aged 2 to 5 years with mild to moderate AD, with a Body Surface Area (BSA) ranging from 3% to 82% and a mean BSA of 22%. Significant improvements in symptoms were observed as early as Week 1, with 25.4% of children achieving Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) scores of “clear” or “almost clear” by Week 4. This compares favorably to just 10.7% of those using the placebo (p < 0.0001). Almost 40% of children treated with roflumilast achieved a 75% reduction in EASI score compared to 20.6% in the vehicle group.

In addition, over a third of patients who experienced moderate to severe itch at baseline achieved a rapid 4-point reduction in their Worst Itch Numeric Rating Scale (WI-NRS) score, compared to 18% of placebo (p = 0.0002). Furthermore, the safety profile of roflumilast in the INTEGUMENT-PED trial was favorable with a low incidence of adverse events, aligning with safety data observed in older populations using higher concentrations of 0.15%.

The targeted mechanism of this PDE4 inhibitor addresses AD’s inflammatory pathways in a new way, reducing inflammation while minimizing potential adverse effects. If approved, roflumilast would be a new steroid-free, once-daily topical therapy for pediatric patients as existing treatments for this vulnerable group remain limited.

“Topical treatments prescribed to young AD patients today can have significant shortcomings, which lead to difficult trade-offs between efficacy, safety, and tolerability. Our clinical trials demonstrate that investigational ZORYVE cream 0.05% effectively relieves the itchy rash of AD in these very young children, with a safe and tolerable profile that dermatology clinicians trust from their experience with our ZORYVE portfolio,” president and CEO of Arcutis, Frank Watanabe, said in a statement. “Our commitment to helping people with immune-mediated dermatological diseases is underscored by our efforts to provide an alternative to steroids with a new targeted topical therapy option with the potential to advance the standard of care for the approximately 1.8 million children between the ages of 2 and 5 living with AD.”¹

Roflumilast cream 0.15% is already approved by the FDA for patients 6 years of age and older. The 0.3% version is also approved for plaque psoriasis treatment. A Prescription Drug User Fee Act (PDUFA) target action date has been set for October 13, 2025.

References

1. U.S. FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis. News release. Arcutis Biotherapeutics. Published February 26, 2025. Accessed February 26, 2025. https://www.arcutis.com/u-s-fda-accepts-supplemental-new-drug-application-for-arcutis-zoryve-roflumilast-cream-0-05-for-the-treatment-of-children-aged-2-to-5-with-mild-to-moderate-atopic-dermatitis/

2. Arcutis announces publication of positive data from INTEGUMENT-PED trial evaluating ZORYVE® (roflumilast) cream 0.05% in children 2 to 5 years old with mild to moderate atopic dermatitis in pediatric dermatology. News release. Arcutis Biotherapeutics. Published February 24, 2025. Accessed February 26, 2025. https://www.arcutis.com/arcutis-announces-publication-of-positive-data-from-integument-ped-trial-evaluating-zoryve-roflumilast-cream-0-05-in-children-2-to-5-years-old-with-mild-to-moderate-atopic-dermatitis-in-pediat/