FDA accepts roflumilast cream 0.05% sNDA for children with atopic dermatitis

FDA accepts roflumilast cream 0.05% sNDA in children with atopic dermatitis | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

On February 26, 2025, roflumilast cream 0.05% (Zoryve; Arcutis Biotherapeutics) took a step forward on the FDA pipeline, as the federal agency has accepted the topical cream's supplemental new drug application (sNDA) to treat atopic dermatitis (AD) in children aged 2 to 5 years, according to a press release from Arcutis.¹

The 0.05% formulation of the once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor is being evaluated for patients with mild-to-moderate AD, with a prescription drug user fee act date for potential FDA approval set for October 13, 2025.¹

Arcutis submitted the sNDA on December 16, 2024, based on data from multiple studies, including the INTEGUMENT-PED (NCT04845620) phase 3 trial involving 652 children with a mean AD Body Surface Area (BSA) of 22%.²

"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 INTEGUMENT-PED clinical trial investigator, said in a statement.¹

"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," said Gonzalez. "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

WATCH: Key atopic dermatitis approvals are changing the treatment landscape

In INTEGUMENT-PED, data demonstrated that 25.4% of children treated with roflumilast 0.05% achieved a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘Clear’ or ‘Almost Clear’, plus a 2-grade improvement from baseline, compared to 10.7% of children treated with vehicle (P < 0.0001). Improvements were also observed as early as week 1.¹

Data published in Pediatric Dermatology on February 20, 2025, and reported by Contemporary Pediatrics, demonstrated that of the 437 children aged 2 to 5 years old who were treated with roflumilast 0.05%, 39.4% achieved a 75% improvement in the Eczema Area and Severity Index (EASI-75).³

Additionally, Within the first 24 hours of roflumilast 0.05% treatment, rapid itch improvement was observed, measured by the change from baseline in daily Worst Itch Numeric Scale compared to vehicle (P ≤ .0014).³

Results from the INTEGUMENT-PED trial demonstrate that ZORYVE cream 0.05% can quickly and reliably improve the symptoms of AD, especially itch," said Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego, lead author of the Pediatric Dermatology publication, at the time of data publication.³

"The publication of these results and the entire clinical development program highlight that ZORYVE cream 0.05%, if approved, could fill a significant gap in the current treatment landscape for a once-daily steroid-free topical therapy that is appropriate for both the short and long-term management of AD, key concerns for young patients and their caregivers," said Eichenfield.³

In August 2024, Contemporary Pediatrics reported on phase 3 data from the INTEGUMENT-OLE study (NCT04804605), a multicenter, open-label, extension study evaluating long-term safety of roflumilast cream 0.05% in children aged 2 to 5 years enrolled 562 individuals after completing the INTEGUMENT-PED phase 3 trial.³

In the extension study, 71.9% of participants who rolled over from the roflumilast treatment arm in INTEGUMENT-PED achieved a 75% improvement from baseline Eczema Area and Severity Index (EASI-75) after 56 weeks.³

"These results build upon the findings from the Phase 3 trial of roflumilast cream 0.05% that demonstrated rapid efficacy within the first 4 weeks of treatment, and further showed long-term durable efficacy and tolerability of investigational roflumilast cream, with continued improvement over the course of the long-term study," said Adelaide Hebert, MD, professor of dermatology and pediatrics at UTHealth Houston, and INTEGUMENT trial investigator, at the time the data was published.³

Click here for more on the INTEGUMENT-OLE study.

Currently, roflumilast cream, 0.3% is approved by the FDA to topically treat plaque psoriasis in patients 6 years and older, while roflumilast cream, 0.15% is approved by the federal agency to treat mild-to-moderate AD in patients 6 years and up.¹

Click here for more on roflumilast 0.15% to treat AD in patients 6 years and older.

References:

1. US 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. Arcutis Biotherapeutics. Press release. February 26, 2025. Accessed February 26, 2025. https://www.globenewswire.com/news-release/2025/02/26/3032866/0/en/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.html

2. Ebert, M. Roflumilast 0.05% sNDA submitted to FDA for atopic dermatitis in children 2 to 5 years. Contemporary Pediatrics. December 16, 2024. Accessed February 26, 2025. https://www.contemporarypediatrics.com/view/roflumilast-0-05-snda-submitted-to-fda-for-atopic-dermatitis-in-children-2-to-5-years

3. Fitch, J. Roflumilast cream 0.05% demonstrates eczema area severity, itch improvement for pediatric atopic dermatitis. Contemporary Pediatrics. February 24, 2025. Accessed February 26, 2025. https://www.contemporarypediatrics.com/view/roflumilast-cream-0-05-demonstrates-eczema-area-severity-itch-improvement-pediatric-atopic-dermatitis