Arcutis Submits sNDA for Roflumilast Cream 0.3% to Treat Plaque Psoriasis in Patients as Young as 2

Today, Arcutis Biotherapeutics announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication of roflumilast cream 0.3% (Zoryve) for the treatment of plaque psoriasis in children down to the age of 2.¹

“This submission represents another important step forward in our goal to establish ZORYVE as foundational therapy for young children suffering with inflammatory skin diseases,” said Frank Watanabe, president and CEO of Arcutis. “Historically, many treatments for inflammatory skin diseases were not studied in children, creating challenges for the clinicians who treat these vulnerable patients. Arcutis is committed to helping to address this gap in treatment through conducting trials of ZORYVE in pediatric patients across a range of inflammatory skin diseases.”¹

Plaque psoriasis, the most common form of psoriasis in children, often appears in sensitive areas such as the face or intertriginous areas. This makes long-term treatment difficult for clinicians, parents, and other caregivers. The once-daily, steroid-free cream addresses this challenge and acts as an alternative to topical steroids and vitamin-D analogs. The non-greasy formula is the only topical indicated for intertriginous psoriasis and does not include propylene glycol, polyethylene glycol, ethanol, fragrances, or other sensitizing excipients or irritants.

“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. There is a significant unmet need for non-steroidal options that can effectively treat plaque psoriasis over the long-term,” said Adelaide Hebert, MD, professor and chief of pediatric dermatology at UTHealth Houston. “If approved, investigational ZORYVE cream could be an important first-line treatment option for children as young as age 2.”¹

The sNDA submission is supported by results from the Maximal Usage Systemic Exposure (MUSE) study, a 4-week trial in patients aged 2 to 5 years with plaque psoriasis. It also includes data from a long-term open-label study that demonstrates roflumilast’s long-term safety, tolerability, and efficacy in multiple age ranges (ARQ-151-306).

Roflumilast cream 0.3% is currently approved in adults and children aged 6 years and over.² The topical foam version is approved for patients with plaque psoriasis 12 years of age and older. With an FDA approval, this cream therapy would become the first and only topical PDE4 inhibitor for pediatric patients with plaque psoriasis in this younger age group.

"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.

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. Globe Newswire. News release. September 3, 2025. Accessed September 3, 2025. https://www.globenewswire.com/news-release/2025/09/03/3143886/0/en/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.html

2. FDA approves Arcutis’ ZORYVE (roflumilast) cream 0.3% for the treatment of psoriasis in children ages 6 to 11. Arcutis Biotherapeutics. News release. October 6, 2023. Accessed September 3, 2025. https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-03-treatment