FDA Expands Roflumilast Access to Children as Young as Age 2

Today, the US FDA approved roflumilast (Zoryve; Arcutis) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years. The once-daily, steroid-free formulation provides clinicians with a new therapeutic option for long-term management of pediatric eczema, a chronic inflammatory skin disorder that affects an estimated 1.8 million topically treated children in this age group in the US alone.¹

"Roflumilast 0.05% cream for young pediatric AD patients fills an unmet need for effective and safe non-steroidal topicals in young children who do not require systemic therapy or as adjunctive therapy for those on systemic therapy who require additional topical care," said Christoper Bunick, MD, PhD, associate professor of dermatology at the Yale School of Medicine and editor in chief of Dermatology Times, in an exclusive statement. "Research has demonstrated the unique biochemical properties of roflumilast that underlie its potency and efficacy across psoriasis, seborrheic dermatitis, and atopic dermatitis; however, it is roflumilast's consistent safety and tolerability profile that justifies its current approval in children ages 2 to 5. Parents will be thrilled to have this option for their young kids."

Key Findings and Clinical Impact

The FDA approval was supported by data from the INTEGUMENT-PED (NCT04845620) and INTEGUMENT-OLE (NCT04804605) trials, which demonstrated that roflumilast cream 0.05% produced rapid improvement in disease severity and clinically meaningful improvement in itch.

“It is essential to have safe and effective treatments for children, who are often diagnosed with atopic dermatitis at a young age and can live with the condition across their lifetime. Young children often experience widespread disease, affecting large portions of their skin. Although topical steroids have been the standard treatment for years, they are not appropriate for long-term use,” said Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and INTEGUMENT study investigator, in a news release. "In clinical trials, [roflumilast] cream 0.05% rapidly improved the severity and extent of eczema (AD) signs and symptoms, with approximately 40% of children achieving a 75% improvement from baseline as measured by EASI, and more than one-third (35%) achieving a clinically meaningful improvement in itch intensity, both in only 4 weeks. With this approval, health care providers and families have an effective new treatment option for young children with atopic dermatitis.”

The cream was well tolerated, with minimal local irritation and a safety profile similar to vehicle. Its formulation omits common sensitizing agents, such as propylene glycol, polyethylene glycol, ethanol, and fragrances, making it suitable for use on sensitive skin areas, including the face, neck, and intertriginous regions.

Background: Addressing an Unmet Need

AD often manifests early in life, driven by immune dysregulation and impaired barrier function. The resulting itch–scratch cycle can exacerbate inflammation and significantly affect quality of life for both patients and caregivers. Standard therapy typically begins with topical corticosteroids, but their potential for adverse effects with chronic use has limited their suitability for long-term disease control.

For parents, the disease’s burden extends beyond the skin. “This condition doesn’t just affect the child’s skin—it can affect the whole family by causing sleep disruption, emotional distress, and social isolation,” said Korey Capozza, MPH, founder of Global Parents of Eczema Research.

Mechanism and Clinical Positioning

Roflumilast, a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor, reduces inflammation by inhibiting the release of pro-inflammatory cytokines. The 0.05% concentration was formulated specifically for pediatric patients to achieve optimal efficacy with a favorable safety margin.

Roflumilast 0.05% is approved for once-daily use on any affected skin area and may be applied continuously or intermittently as part of long-term disease management. The non-steroidal, anti-inflammatory mechanism provides an alternative for clinicians seeking to reduce cumulative topical corticosteroid exposure in young patients.

Expanding the Roflumilast Portfolio

The approval marks the 6th FDA authorization for roflumilast in just over 3 years. Arcutis has also submitted a supplemental NDA for roflumilast cream 0.3% to treat plaque psoriasis in children aged 2 years and older. Data from the MUSE study supported this application, showing low systemic absorption and sustained efficacy in younger populations.

"Psoriasis in kids is on the rise, yet our treatment strategies for kids in preschool have not changed in decades. We need more options to treat plaque psoriasis in pediatric patients and we need them to be steroid-free, so I am so excited to see Arcutis pursue studies and indications for our littlest psoriasis patients," Lisa Swanson, MD, FAAD, pediatric dermatologist at Ada West Dermatology in Boise, Idaho, told Dermatology Times at the time of submission.²

Arcutis president and CEO Frank Watanabe stated that roflumilast “provides patients and their families with a treatment option for long-term, continuous use, helping maintain clear skin and limiting cumulative topical steroid exposure.”

Access and Availability

Arcutis says it plans to make rolfumilast cream 0.05% widely available through wholesalers and pharmacies in the United States by late October 2025. The company’s Zoryve Direct program assists families in navigating insurance processes and offers copay savings for eligible patients. In addition, the Arcutis Cares patient assistance program provides medication at no cost for financially eligible uninsured or underinsured individuals.

Looking Ahead

The approval of roflumilast cream 0.05% offers clinicians a steroid-free, once-daily topical therapy with demonstrated efficacy and tolerability in children as young as 2 years old. As the management of pediatric AD continues to evolve toward safer, more targeted approaches, roflumilast provides an important new option that aligns with long-term disease control goals and caregiver preferences. For clincians, it represents a practical addition to the therapeutic toolkit, bridging the gap between conventional steroid therapy and newer systemic biologics in early childhood eczema management.

References

1. FDA approves Arcutis’ ZORYVE (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5. News release. Arcutis. October 6, 2025. Accessed October 6, 2025. https://www.globenewswire.com/news-release/2025/10/06/3161656/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-05-for-the-Treatment-of-Atopic-Dermatitis-in-Children-Ages-2-to-5.html
2. Bosslett M. Arcutis submits sNDA for roflumilast cream 0.3% to treat plaque psoriasis in patients as young as 2. News article. Dermatology Times. September 3, 2025. Accessed October 6, 2025. https://www.dermatologytimes.com/view/arcutis-submits-snda-for-roflumilast-cream-0-3-to-treat-plaque-psoriasis-in-patients-as-young-as-2