FDA Approves Roflumilast Cream 0.3% for Plaque Psoriasis in Children as Young as 2

The FDA has approved a supplemental New Drug Application expanding the indication for roflumilast (Zoryve; Arcutis Biotherapeutics) cream 0.3%, making it the first once-daily, steroid-free topical therapy approved for plaque psoriasis in children as young as 2 years old.¹

The approval extends use of the topical phosphodiesterase type 4 (PDE4) inhibitor to children ages 2 to 5, including for use on intertriginous areas such as skin folds. This marks the seventh FDA approval for roflumilast in 4 years, reflecting the drug's expanding role across inflammatory dermatoses.¹

A Persistent Need in Pediatric Psoriasis Care

Plaque psoriasis affects nearly 9 million individuals in the United States, presenting with itch, scaling, redness, and flaking that can appear anywhere on the body, including thin-skinned areas like the face and genitals. In patients with darker skin tones, plaques may present as more grayish, purplish, or brown rather than the classic red appearance. According to Arcutis president and CEO Frank Watanabe, children with plaque psoriasis under age 6 have historically had few treatment options suitable for long-term use, leaving families and clinicians to manage a chronic, progressive condition with limited choices. The newly approved indication for roflumilast cream 0.3% is intended to directly address that gap.¹

Clinical Evidence Supporting the Expanded Indication

The pediatric approval was supported by an open-label study evaluating pharmacokinetics, safety, tolerability, and exploratory efficacy of roflumilast cream 0.3% in children with plaque psoriasis affecting at least 2% of body surface area, along with a long-term safety extension study, ARQ-151-306, assessing children ages 2 to 5 over up to 24 weeks of treatment.¹

Investigators reported that safety and efficacy profiles in this younger population were generally consistent with those previously established in the pivotal DERMIS-1 and DERMIS-2 phase 3 trials. Those identical, double-blind, vehicle-controlled trials enrolled 439 and 442 participants, respectively, with patients aged 2 years and older with 2% to 20% body surface area involvement; roughly 40% of roflumilast-treated participants achieved a 75% reduction in Psoriasis Area and Severity Index (PASI-75) scores by week 8, compared with single-digit percentages in the vehicle arms (P < .001 for both trials). Roflumilast cream and vehicle demonstrated similar rates of treatment-related adverse events, with no serious adverse events reported in either trial.^1,2

Mechanism of Action and Place in Therapy

Roflumilast is a topical, targeted PDE4 inhibitor. By inhibiting PDE4, an intracellular enzyme implicated in inflammatory dermatologic disease, the cream reduces production of pro-inflammatory mediators, decreasing skin inflammation and helping rebalance the cutaneous immune response. Notably, the cream carries no restrictions on duration of use and is approved for application anywhere on the body, including sensitive intertriginous areas, distinguishing it from topical corticosteroids that typically carry such limitations.¹

Access and Pharmacist Counseling Considerations

Arcutis offers support for patients prescribed roflumilast through its Zoryve Direct Program, which assists with insurance navigation, adherence, and a savings card program for eligible commercially insured patients, alongside the Arcutis Cares patient assistance program for uninsured or underinsured individuals. Pharmacists counseling caregivers of young patients should emphasize the once-daily, steroid-free dosing regimen and the absence of duration-of-use restrictions, key differentiators from prior topical standards of care in this population.¹

REFERENCES

1. FDA Approves Arcutis' Zoryve (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2. Arcutis Biotherapeutics. June 29, 2026. Accessed June 30, 2026. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-3-for-the-treatment-of-plaque-psoriasis-in-children-as-young-as-age-2/

2. Lebwohl MG, Kircik LH, Moore AY, et al. Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials. JAMA. 2022;328(11):1073-1084. doi:10.1001/jama.2022.15632