Arcutis Submits sNDA for Roflumilast Cream 0.3% for Psoriasis in Children Aged 2-5 Years

Arcutis Biotherapeutics, Inc. submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for roflumilast cream 0.3% (Zoryve) for plaque psoriasis in pediatric patients as young as 2 years old, potentially expanding the treatment’s indication.1

This September 3 announcement highlighted that, if roflumilast cream’s sNDA clears and the age limit for roflumilast is expanded, it would be the first and only topical phosphodiesterase 4 (PDE4) inhibitor indicated for psoriasis among patients in this age group. Plaque psoriasis, the most prevalent form of this inflammatory skin disease among children, impacts nearly 9 million individuals in the US and is characterized by pruritus, redness, scaling, flaking, and pain.

“Today, there are very limited FDA-approved treatment options for plaque psoriasis for children under 6, who often present with disease on sensitive skin such as the face and intertriginous areas,” Adelaide Hebert, MD, professor and chief of pediatric dermatology at UTHealth Houston, said in a statement.1 “There is a significant unmet need for non-steroidal options that can effectively treat plaque psoriasis over the long-term. If approved, investigational [roflumilast] cream could be an important first-line treatment option for children as young as age 2.”

Psoriasis is a condition that can present on any area of the body, but among children, the skin disease often appears in sensitive or intertriginous regions. This complicates treatment for such patients and can negatively impact the quality of life for both patients and their families and caregivers.

Roflumilast cream currently holds the position as the most prescribed branded topical across three inflammatory skin conditions combined—atopic dermatitis, plaque psoriasis, and seborrheic dermatitis. The drug was designed as a next-generation, highly potent, and selective PDE4 inhibitor. PDE4 is a validated target in dermatology, promoting the release of pro-inflammatory mediators while suppressing anti-inflammatory ones.

Roflumilast cream’s steroid-free, non-greasy formulation was also designed to avoid sensitizing or irritating excipients such as polyethylene glycol, propylene glycol, ethanol, and fragrances. This formulation of this medication was designed for once-daily use. It is also the only topical therapy specifically approved for intertriginous psoriasis and has shown efficacy, tolerability, and safety among both adults and pediatric patients.

One recently highlighted set of findings on roflumilast cream 0.3% suggested that the topical may improve signs and symptoms of plaque psoriasis among patients aged 2 - 11 years under maximal use conditions.2 These data were authored by Hebert and a team of other investigators.

At present, roflumilast cream 0.3% is approved by the FDA for psoriasis in individuals aged 6 years and older. This new sNDA by Arcutis is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) trial involving children aged 2 - 5 years with plaque psoriasis, in addition to data from an ongoing long-term open-label study.3 The long-term results confirmed the treatment’s sustained efficacy and highlighted its favorable safety and tolerability findings across pediatric age cohorts.

“This submission represents another important step forward in our goal to establish ZORYVE as foundational therapy for young children suffering with inflammatory skin diseases,” Frank Watanabe, president and CEO at Arcutis, said in a statement.1 “Historically, many treatments for inflammatory skin diseases were not studied in children, creating challenges for the clinicians who treat these vulnerable patients.”

References

1. Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children Ages 2 to 5. Arcutis Biotherapeutics, Inc. September 3, 2025. https://investors.arcutis.com/news-releases/news-release-details/arcutis-submits-supplemental-new-drug-application-zoryver-1.

2. Smith T. Roflumilast Cream 0.3% Effective for Psoriasis in Children Aged 2 to 11 Years. HCPLive. August 27, 2025. Accessed September 3, 2025. https://www.hcplive.com/view/roflumilast-cream-effective-psoriasis-children-aged-2-11-years.

3. Arcutis Enrolls First Child in INTEGUMENT-INFANT Evaluating ZORYVE® (roflumilast) Cream 0.05% in Infants with Atopic Dermatitis. News release. Arcutis Biotherapeutics. June 10, 2025. Accessed September 3, 2025. https://investors.arcutis.com/news-releases/news-release-details/arcutis-enrolls-first-child-integument-infant-evaluating-zoryver.