FDA Approves Roflumilast 0.3% Cream for PsO in Children 2-5 Years

The US Food and Drug Administration (FDA) has approved roflumilast cream 0.3% (Zoryve; Arcutis Biotherapeutics) for the treatment of plaque psoriasis in pediatric patients as young as 2 years of age, expanding the topical phosphodiesterase 4 (PDE4) inhibitor's existing indication in psoriasis, which had been limited to patients aged 6 and older, according to an announcement by Arcutis.¹ The approval makes roflumilast cream the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children under 6.

Roflumilast cream 0.3% received its initial psoriasis approval in patients aged 6 and older and is currently the only topical therapy specifically approved for intertriginous psoriasis.² The supplemental New Drug Application supporting the pediatric expansion was submitted in September 2025, backed by data from a 4-week Maximal Usage Systemic Exposure (MUSE) trial in children aged 2–5 with plaque psoriasis and an ongoing long-term open-label study.²

“Having… roflumilast 0.3% for plaque psoriasis for kids, is huge in this age group. Historically, there have not been many treatments, and really mostly relied on topical steroids,” Jennifer Soung, MD, Director of Clinical Research, Southern California Dermatology and faculty at Harbor-UCLA Medical Center, said. “So, having a once daily non-steroid cream for these kids for a chronic disease is really, really important. So, patients and their families can feel really reassured. They can use these non-steroid creams on all areas of the body, and there's no limit on duration,”

Efficacy and safety data supporting the pediatric expansion

Data from a pair of Phase 2, open-label MUSE trials — one in children aged 2–5 years (n = 10; NCT04746911) and one in children aged 6–11 years (n = 20; NCT04655313) — evaluated pharmacokinetics, safety, and efficacy of once-daily roflumilast cream 0.3% under maximal use conditions in patients with BSA involvement ≥2% and Investigator Global Assessment (IGA) ≥2.³ Evidence of systemic absorption of roflumilast and its active N-oxide metabolite was detected in most participants in both trials, consistent with prior Phase 3 pharmacokinetic data in adults and adolescents.³

At 4 weeks in the 2–5 age cohort, 90% of participants achieved IGA success, 90% achieved PASI-75, and 90% met Worst Itch Numeric Rating Scale (WI-NRS) success criteria (defined as a ≥4-point reduction from baseline, caregiver-reported in children under 8 years).³ Overall tolerability was favorable across both age groups, with results described as consistent with Phase 3 findings in older patients. A separate long-term open-label study (ARQ-151-306) enrolling participants aged 2 and older confirmed sustained efficacy and tolerability across pediatric age cohorts over extended treatment durations.²

Roflumilast cream is a next-generation, highly selective PDE4 inhibitor formulated without steroids, polyethylene glycol, propylene glycol, ethanol, or fragrances. Its steroid-free composition and once-daily application are particularly relevant in the under-6 age group, where prolonged corticosteroid use on facial or intertriginous skin carries known tolerability risks and where long-term topical options have historically been limited.²

“I love [roflumilast] as a first line treatment. I think it's so valuable having a once daily steroid-free treatment for those young children, where patients and their families can feel confident in applying it anywhere on the skin, and for no, there's no limit on duration. I also really love the formulation, it doesn't have any irritants, and even has moisturizing properties,” Soung said.

Roflumilast cream is currently approved for 3 inflammatory skin conditions — atopic dermatitis, plaque psoriasis, and seborrheic dermatitis — and is the most prescribed branded topical across all three combined. Arcutis is also evaluating roflumilast cream 0.05% (INTEGUMENT-INFANT) in infants with atopic dermatitis, continuing the company's effort to establish the PDE4 inhibitor class as a foundational pediatric dermatology option.³

“Parents and caregivers of young children with plaque psoriasis have faced a significant treatment gap for years, with very limited options, even though this skin condition can have a profound impact on the child and the entire family,” Leah Howard, president and chief executive officer, National Psoriasis Foundation, said in a statement.1 “The FDA approval of a once-daily, steroid-free topical treatment for children as young as 2 introduces an important new treatment option for a largely overlooked population and represents a significant advancement in pediatric psoriasis care.”

References

1. Acrutis Biotherapeutics. FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2. June 29, 2026. Accessed June 29, 2026. https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-03-treatment-0

2. Arcutis Biotherapeutics, Inc. 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. Press release. September 3, 2025. https://investors.arcutis.com/news-releases/news-release-details/arcutis-submits-supplemental-new-drug-application-zoryver-1

3. Hebert A, et al. Early evidence of safety, clinical benefit, and pharmacokinetics of roflumilast cream 0.3% once daily for treatment of mild or moderate plaque psoriasis in children aged 2–11 years. Pediatr Dermatol. 2025. doi:10.1111/pde.70013