sNDA for Roflumilast Cream 0.05% for the Treatment of AD in Children Aged 2 to 5 Years Gets FDA Nod

The FDA today accepted a supplemental New Drug Application (sNDA) for roflumilast cream 0.05% (Zoryve; Arcutis Biotherapeutics) for the treatment of mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years, according to a news release from Arcutis. The agency set a Prescription Drug User Fee Act (PDUFA) target action date for October 13, 2025.

_{©New Africa/stock.adobe.com}

If approved, roflumilast cream 0.05% would provide a new topical treatment option for approximately 1.8 million young children in the United States affected by AD, the company said.

“In clinical trials, investigational [roflumilast] 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,” Mercedes E. Gonzalez, MD, medical director of Pediatric Skin Research, LLC, and an investigator in the INTEGUMENT PED clinical trial, said in the statement. “If approved, [roflumilast ] 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.”

The sNDA is supported by data most recently from the INTEGUMENT-PED phase 3 trial, announced earlier this week, a pivotal long-term extension study (INTEGUMENT-OLE), and a phase 1 pharmacokinetic study. In the INTEGUMENT-PED trial, which enrolled 652 children with AD affecting 3% to 82% of body surface area (mean: 22%), roflumilast demonstrated significant improvement as early as week 1. Investigators reported at week 4, 25.4% of children treated with roflumilast cream 0.05% achieved validated Investigator Global Assessment–Atopic Dermatitis (vIGA-AD) scores of “clear” or “almost clear" compared to 10.7% of those receiving vehicle (P <.001). Almost 40% of children treated with roflumilast achieved a 75% reduction in EASI score compared to 20.6% of those treated with vehicle.

Itch relief with roflumilast cream 0.05% was rapid and significant, according to the statement. Among children with a baseline Worst Itch Numeric Scale (WI-NRS) score of 4 or greater (moderate to severe), 34.8% achieved a 4-point reduction after 4 weeks of treatment, compared to 18.0% in the vehicle group (P =.002).

The cream was well tolerated, with a safety profile consistent with previously approved roflumilast cream formulations for older populations using concentrations of 0.15%.

“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 [roflumilast] 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 [roflumilast] portfolio,” Frank Watanabe, president and CEO of Arcutis, said in the news release. “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.”

Roflumilast is a next-generation topical phosphodiesterase-4 inhibitor, designed to modulate inflammatory pathways in dermatologic conditions. Currently, roflumilast cream 0.3% is FDA-approved for the treatment of plaque psoriasis in patients 6 years and older, while roflumilast cream 0.15% is approved for mild to moderate AD in the same age group.

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/