FDA Accepts sNDA for Zoryve Cream for Atopic Dermatitis Treatment in Young Children

Arcutis Biotherapeutics, Inc., a biopharmaceutical company specializing in immuno-dermatology, recently announced that the FDA accepted a supplemental New Drug Application (sNDA) for Zoryve (roflumilast) cream 0.05%.

This once-daily topical treatment is the latest phosphodiesterase-4 (PDE4) inhibitor designed for mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025, for its decision on the application.

According to Boston Children’s Hospital, AD is the most common chronic skin disorder in children causing inflammation, itchiness and flakes to the skin.

Affecting approximately 1.8 million children aged 2 to 5 in the U.S., AD can occur in about 1 in 5 children, with most cases developing before 5 years of age, according to Riley Children’s Health.

The PDE4 inhibitor found in Zoryve helps regulate inflammation and is used to treat skin conditions.

For instance, the FDA has approved Zoryve cream 0.3% for plaque psoriasis and patients 9 years and older with seborrheic dermatitis. Zoryve cream 0.15% is approved for treating mild to moderate AD in those 6 and older.

The wholesale price of the foam version of Zoryve 0.3% was $858 per tube when first approved in late 2023. The wholesale price of Zoryve 0.15% is roughly $1,107 per tube.

The Zoryve team was contacted for the price of the 0.05% cream.

Clinical trial results have been promising for the recently sNDA accepted drug, demonstrating the effectiveness in young children with AD.

This acceptance is supported by data from the INTEGUMENT-PED Phase 3 clinical trial, the INTEGUMENT-OLE long-term extension study and a Phase 1 pharmacokinetic study.

The INTEGUMENT-PED trial studied 652 children aged 2 to 5 with different levels of AD. Results showed significant improvements within the first week of treatment.

By Week 4, 25.4% of children using Zoryve cream 0.05% achieved success on the validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) scale, compared to 10.7% in the placebo group.

The treatment also provided rapid itch relief, with over one-third of children experiencing a four-point reduction on the Worst Itch Numeric Scale (WI-NRS), compared to 18.0% in the placebo group.

In addition, the study also confirmed the safety and tolerability of Zoryve cream 0.05%, with adverse event rates remaining low.

The safety profile was consistent with findings in older pediatric and adult patients treated with Zoryve cream 0.15% for mild to moderate AD.

Mercedes E. Gonzalez, M.D., medical director of Pediatric Skin Research, LLC, and a clinical trial investigator, highlighted the importance of the cream's efficacy and favorable safety profile for long-term treatment in children.

Gonzalez added that while AD lowers the quality of life for the affected child and caregiver, an approved Zoryve cream 0.05% “will provide a new treatment option that offers long-term relief and can help alleviate the disease burden for children and their caregivers.”

This development comes at a time where there is an unmet need in pediatric AD treatment and current options often involve compromises between efficacy and safety, according to Frank Watanabe, president and CEO of Arcutis.

He added the company is commitment to offering an alternative to steroids, which remain a common but imperfect treatment option.

While results are promising for this new treatment, the use of Zoryve cream 0.05% comes with certain safety warnings that should be considered.

This cream is generally safe but is suggested to not be used by patients with moderate to severe liver impairment.

Common side effects of the 0.3% formulation for plaque psoriasis include diarrhea, headache, and nausea; while the 0.15% formulation for atopic dermatitis most frequently causes headache, nausea and application site pain.

Looking ahead, the potential approval of Zoryve cream 0.05% could mark a significant advancement in treating young children with AD.