Arcutis Biotherapeutics has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) seeking to expand the indication for roflumilast (Zoryve) cream 0.05% to include the topical treatment of mild to moderate atopic dermatitis in infants as young as 3 months.
Announced by Arcutis on April 27, 2026, the submission would extend the agent’s current approval, which covers children aged 2 to 5 years, down to infants aged 3 months to less than 24 months.1
The filing adds to a rapidly growing pediatric label for roflumilast cream 0.05%, a once-daily, steroid-free topical phosphodiesterase-4 (PDE4) inhibitor, which is 1 of 2 FDA-approved topical nonsteroidal anti-inflammatory agents, and comes less than a month after the American Academy of Dermatology issued a strong recommendation for roflumilast cream 0.05% in children aged 2 to 5 years in its first pediatric atopic dermatitis guidelines published in April 2026.1,2
FREQUENTLY ASKED QUESTIONS
What age group is covered by this roflumilast cream 0.05% sNDA submission?
The submission seeks to expand the indication to infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. Roflumilast cream 0.05% is currently approved for children aged 2 to 5 years.
What data support the sNDA for roflumilast cream 0.05% in infants?
The sNDA is supported by a Phase 1 PK study and the Phase 2 INTEGUMENT-INFANT trial, both evaluating once-daily roflumilast cream 0.05% over four weeks in infants aged 3 months to less than 24 months.
How does roflumilast cream 0.05% work in atopic dermatitis?
Roflumilast inhibits phosphodiesterase-4 (PDE4), an intracellular enzyme that drives pro-inflammatory mediator production in the skin, reducing cutaneous inflammation without the mechanism-based risks associated with topical corticosteroids.
“Atopic dermatitis often begins within the first year of life, yet treatment options for infants are extremely limited,” said Mercedes E. Gonzalez, MD, medical director of Pediatric Skin Research, LLC and an INTEGUMENT-INFANT clinical trial investigator. “Safe and effective long-term therapies suitable for use anywhere on the body, including sensitive regions such as the face and skin folds, remain an important unmet need for infants with atopic dermatitis. If approved, [roflumilast] cream 0.05% could offer a much-needed nonsteroidal treatment option developed specifically for very young children, including infants.”
INTEGUMENT-INFANT trial design and efficacy results
The sNDA is supported by 2 studies evaluating once-daily roflumilast cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. The phase 1 open-label pharmacokinetic (PK) study enrolled 19 infants over 4 weeks and demonstrated PK, safety, and efficacy profiles consistent with those observed in prior pediatric atopic dermatitis studies in older children, according to Arcutis’ release. The phase 2 INTEGUMENT-INFANT open-label study enrolled 101 infants and assessed safety, tolerability, and efficacy over 4 weeks.1
Among the 96 infants who completed 4 weeks of treatment in INTEGUMENT-INFANT, 34.4% achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success, which was defined as a score of 0 (clear) or 1 (almost clear) with an improvement of 2 grades or more from baseline. In addition, 49% of infants achieved a vIGA-AD score of clear or almost clear at week 4, with 24% reaching that threshold as early as week 2 and measurable improvement was observed as early as week 1.
Among infants with at least mild scalp involvement at baseline, 67.5% (27/40) achieved vIGA-scalp success at week 4. The Eczema Area and Severity Index–75 response rate was 58.3% at week 4, with 34% achieving that threshold by week 2.
Caregiver-reported itch outcomes also demonstrated rapid improvement: 72.7% of infants achieved Worst Scratch Itch Numeric Rating Scale success, which was defined as an improvement of 4 points or more, at week 4 (n=77), and 60.3% at week 2 (n=73). Pruritus improvements were also noted as early as 10 minutes after application, as measured by the Dynamic Pruritus Scale.1
Roflumilast cream 0.05% safety and tolerability in infants
In the INTEGUMENT-INFANT study, roflumilast cream 0.05% was well tolerated in infants, with a safety and tolerability profile consistent with prior pediatric experience across the INTEGUMENT program, according to Arcutis.¹ The most frequently reported adverse events were diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting. No new safety signals were identified.
Arcutis highlighted that the 0.05% concentration was specifically selected for children 5 years and younger, in part based on the skin barrier dysfunction characteristic of atopic dermatitis in younger children. The formulation is steroid-free and does not contain sensitizing excipients, including propylene glycol, polyethylene glycol, ethanol, or fragrances.1
If approved, roflumilast cream 0.05% would become the second FDA-approved topical nonsteroidal anti-inflammatory therapy in this age group, and would extend a label already spanning from aged 2 years through adulthood across multiple roflumilast formulations.1
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