FDA Approves Zoryve Cream 0.05% for Young Children with Atopic Dermatitis

Today the U.S. FDA approved Zoryve (roflumilast) cream 0.05% for mild to moderate atopic dermatitis (AD) treatment in children ages 2 to 5, offering a safe and effective steroid-free option for young patients.

The once-daily Zoryve cream 0.05% helps treat AD by reducing the inflammation that causes symptoms. It targets a protein called phosphodiesterase 4 (PDE4), which plays a role in skin inflammation. By targeting this protein, the cream can lower the body’s inflammatory response and help calm irritated skin, improving symptoms quickly anywhere on the body.

Today’s approval comes after the FDA accepted Arcutis’ supplemental New Drug Application (sNDA) for the cream and an initial Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025.

Zoryve targets the most common type of eczema, AD, which affects roughly 1.8 million children aged 2 to 5 in the U.S., occurring in about one in five children, with most cases developing before age 5, according to Riley Children’s Health.

The chronic, relapsing condition typically appears as red, itchy rashes that can affect the face, neck, arms, legs and other parts of the body. Pediatric AD can disrupt sleep, increase the risk of skin infections and place emotional and developmental stress on both children and caregivers.

“Young children are particularly vulnerable to the bothersome symptoms of atopic dermatitis, because their immune system and skin barrier are less developed than those of older children and adults,” Korey Capozza, M.P.H., founder and executive director at Global Parents of Eczema Research, said in today’s announcement.

Zoryve cream 0.05% represents the latest addition to a growing portfolio of Zoryve products, which also include formulations for older children and adults with AD, as well as plaque psoriasis and seborrheic dermatitis.

In July 2022, the FDA approved Zoryve cream for the treatment of plaque psoriasis in adults and adolescents, and the 0.15% cream is approved for treating mild to moderate atopic dermatitis in patients 6 years and older.

“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,” Lawrence F. Eichenfield, M.D., chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and INTEGUMENT study investigator, said in the announcement. “Although topical steroids have been the standard treatment for years, they are not appropriate for long-term use.”

Eichenfield added that in clinical trials, Zoryve cream 0.05% “rapidly” improved the severity and extent of eczema signs and symptoms, with 40% of children achieving a 75% improvement from the start. He also said that more than one-third (35%) achieved a “clinically meaningful improvement in itch intensity,” both in four weeks.

Today’s approval is based on results from the INTEGUMENT-PED phase 3 trial, the INTEGUMENT-OLE long-term extension study and a phase 1 pharmacokinetic study.

In INTEGUMENT-PED, 652 children ages 2 to 5 were treated with either Zoryve cream 0.05% or a placebo once daily for four weeks. The trial showed rapid disease clearance, with improvements seen as early as week 1. By week 4, 25.4% of children achieved vIGA-AD success compared with 10.7% in the placebo group.

The cream also reduced itch, with over one-third of children experiencing a four-point reduction on the Worst Itch Numeric Scale, compared to 18% in the placebo group. Long-term data from INTEGUMENT-OLE also demonstrated that efficacy was maintained for up to 56 weeks, with 71.9% of participants achieving a 75% improvement from baseline in EASI after continued treatment.

In addition, Zoryve cream 0.05% was generally well tolerated in clinical trials. The most common adverse reactions reported with Zoryve in older pediatric and adult populations include headache, nausea, diarrhea and application site discomfort. The 0.05% formulation is not recommended for patients with moderate to severe liver impairment.

Zoryve cream 0.05% is expected to be widely available by the end of October 2025, according to the manufacturer.

When first approved in 2022, Zoryve’s wholesale acquisition cost was $825 per tube, according to an Arcutis spokesperson.

Arcutis has structured patient support programs to assist with access and cost management, including the ZORYVE Direct Program and the Arcutis Cares patient assistance program, which help eligible patients navigate insurance, reduce out-of-pocket costs or obtain medication at no cost.

Melissa Walters, caregiver of a child in the clinical trials, shared her emotional experience with her daughter Kylie by stating that she struggled with AD for so long that it affected the whole family.

“Kylie was uncomfortable, especially at night, which kept the family up and wore on our energy,” Walters said in the announcement. “We enrolled Kylie in the ZORYVE cream clinical trial when she was 2, which resulted in her skin improving and becoming clear. I want to share our story to empower other parents to advocate for their children and talk to their healthcare provider about treatment options that can be used long term.”

The latest approval marks the sixth FDA indication for the Zoryve portfolio in just over three years, highlighting the growing role of this topical therapy in managing inflammatory skin conditions across age groups.