FDA expands roflumilast cream approval to children as young as 2 years with plaque psoriasis

The FDA has expanded the indication for roflumilast (Zoryve; Arcutis Biotherapeutics) cream 0.3% to include the topical treatment of plaque psoriasis in children aged 2 to 5 years, making it the first topical phosphodiesterase-4 (PDE4) inhibitor approved for plaque psoriasis in patients as young as 2 years.¹

The approval broadens the therapy's existing indication, which previously included adults and pediatric patients aged 6 years and older, and provides a new steroid-free treatment option for younger children with plaque psoriasis, including disease affecting sensitive skin areas.^2,3

The expanded approval was supported by data from a Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5 years and a long-term open-label trial demonstrating favorable safety, tolerability, and sustained efficacy across pediatric age groups.²

“Young children with plaque psoriasis face unique challenges, including disease involvement on sensitive skin, such as the face and skin folds. Although topical steroids are commonly used to treat pediatric plaque psoriasis, they are not recommended on sensitive areas or for long-term, continuous use. In clinical studies, ZORYVE cream 0.3% demonstrated consistent safety and efficacy in improving the signs and symptoms of plaque psoriasis as seen in adults and adolescents, and was safe and well tolerated in children as young as age 2. This approval provides physicians and caregivers a targeted topical therapy that can be used anywhere on the body for any duration of time,” said Lisa Swanson, MD, FAAD, board-certified pediatric dermatologist and clinical trial investigator, Ada West Dermatology in a news release from Arcutis Biotherapeutics.¹

Expanding treatment options for younger children

"Plaque psoriasis in young children can be particularly challenging to manage, as it often affects sensitive areas such as the face and intertriginous skin," said Amy Paller, MD, MS, attending physician in dermatology, Walter J. Hamlin Professor and chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine, in a statement. "Effective and well-tolerated treatment options that are gentle enough for these areas are critical to support long-term disease control and improve quality of life for children and their families."

Prior to this approval, treatment options for children younger than 6 years with plaque psoriasis were limited, particularly for long-term management of disease affecting thin-skinned or intertriginous areas.³

"There is a significant unmet need for nonsteroidal options that can effectively treat plaque psoriasis over the long term," said Adelaide Hebert, MD, professor and chief of pediatric dermatology at UTHealth Houston. "Approval of [roflumilast] cream provides an important first-line treatment option for children as young as age 2."

A steroid-free topical option

Roflumilast cream 0.3% is a once-daily, steroid-free topical PDE4 inhibitor formulated without sensitizing excipients such as propylene glycol, polyethylene glycol, ethanol, or fragrances.

"This approval marks an important advancement for families and clinicians caring for young children with plaque psoriasis," said Frank Watanabe, president and CEO of Arcutis Biotherapeutics, in a company statement. "As the first and only topical PDE4 inhibitor indicated for children as young as 2 years, [roflumilast] cream 0.3% offers a steroid-free option that delivers both efficacy and tolerability for this particularly vulnerable group."

Addressing the pediatric burden of psoriasis

Psoriasis affects nearly 9 million people in the United States, according to Arcutis. In pediatric patients, plaques frequently develop on the face, flexural surfaces, and other thin-skinned or intertriginous areas, creating unique treatment challenges and contributing to disease burden.

The pediatric MUSE trial and long-term open-label extension supported the expanded indication, with the long-term study demonstrating "consistent favorable long-term safety and tolerability as well as persistence of efficacy across all age ranges studied," according to the company.

By lowering the approved age from 6 years to 2 years, the FDA approval expands access to a nonsteroidal topical treatment for preschool-aged children with plaque psoriasis, offering clinicians an additional option for long-term disease management.

Current Zoryve indications

In addition to the expanded plaque psoriasis indication for children aged 2 years and older, the roflumilast franchise includes several FDA-approved dermatologic indications:

• Roflumilast cream 0.05% is approved for the treatment of atopic dermatitis in children aged 2 to 5 years.
• Roflumilast foam 0.3% is approved for plaque psoriasis of the scalp and body in adults and pediatric patients aged 12 years and older.
• Roflumilast foam 0.3% is also approved for seborrheic dermatitis in adults and pediatric patients aged 9 years and older.
• Roflumilast cream 0.15% is approved for the treatment of mild-to-moderate atopic dermatitis in adults and pediatric patients aged 6 years and older.

“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,” said Leah Howard, president and CEO, National Psoriasis Foundation in the news release.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. FDA approves Arcutis’ ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children as young as age 2. Press release. Arcutis Biotherapeutics. 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. FDA accepts supplemental new drug application for Arcutios' Zoryve (roflumilast) creamt0.3% for the treatment of plaque psoriasis in children aged 2 to 5 years. Arcutis Biotherapeutics. Press release. November 17, 2025. Accessed June 29, 2026. https://investors.arcutis.com/news-releases/news-release-details/fda-accepts-supplemental-new-drug-application-arcutis-zoryver

3. Ebert M, Fitch J. Arcutis submits sNDA for roflumilast cream 0.3% for treatment of psoriasis in children 2-5 years. Contemporary Pediatrics. September 3, 2025. Accessed June 29, 2026. https://www.contemporarypediatrics.com/view/arcutis-submits-snda-for-roflumilast-cream-0-3-for-treatment-of-psoriasis-in-children-2-5-years