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FDA Approves Roflumilast Cream 0.3% In Children 6 to 11 Years With PsO


The approval provides pediatric patients with a steroid-free topical therapy.



Arcutis Biotherapeutics announced today that the US Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for the expanded indication of roflumilast cream 0.3% (ZORYVE) for the treatment of plaque psoriasis in children ages 6 to 11 years. The topical, once-daily- steroid-free cream can be applied in intertriginous areas and is designed to simplify plaque psoriasis management for pediatric patients, according to the announcement.1

Roflumilast is the only topical treatment that evaluated efficacy in intertriginous areas in pivotal clinical trials and the only therapy specifically indicated for use in these sensitive areas. Additionally, roflumilast does not contain sensitizing excipients or irritants such as propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fragrances.

“Young children with plaque psoriasis lack treatment options, which is why today’s decision by the FDA represents a meaningful advancement for this pediatric population, their parents, and caregivers,” said Patrick Burnett, MD, PhD, FAAD, the chief medical officer at Arcutis, in the news release. “ZORYVE has been shown to be safe, well tolerated, and effective; all critical factors for treating children with plaque psoriasis. We are excited to now be able to expand the availability of ZORYVE to children as young as 6 years old, offering them and their families an important new steroid-free treatment option to consider along with their healthcare providers.”

The FDA’s approval of roflumilast 0.3% is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in pediatric patients ages 6 to 11 years with plaque psoriasis. Pharmacokinetic, safety, tolerability, and efficacy data from MUSE were consistent with data from the DERMIS-1 and DERMIS-2 pivotal phase 3 trials in adults. According to the news release, results from a second MUSE study, in pediatric patients ages 2 to 5 years and data from an ongoing open label extension study to evaluate the long-term safety of roflumilast 0.3% in patients with plaque psoriasis 2 years and older (ARQ-151-306), will be reviewed by the FDA soon.

DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389) were 2 identical, phase 3, randomized, double-blind, vehicle-controlled, 8-week studies of roflumilast 0.3% in patients ≥2 years of age with psoriasis involving 2%-20% body surface area (BSA). Patients were randomized 2:1 to roflumilast or vehicle cream.2

Statistically significant differences favoring roflumilast were observed at week 8 for percentages of patients achieving 50% reduction in PASI (72.1% vs 25.5%) and PASI-HD (79.4% vs 33.1%, respectively). Similar results were observed for percentages of patients achieving 75% reduction at week 8 (40.3% vs 6.5% and 59.9% vs 17.9%, respectively), and percentages of patients achieving 90% reduction at week 8 (19.7% vs 2.3% and 39.9% vs 9.1%, respectively). Lastly, for the percentages of patients achieving 100% reduction in PASI and PASI-HD, significantly more roflumilast-treated patients achieved this end point at week 8 (12.3% vs 0.8%). 2

Recently, Arcutis submitted another sNDA for roflumilast cream 0.15% for the treatment of atopic dermatitis in patients ages 6 years and older.3 Arcutis continues to work towards safe and effective topical therapies for pediatric patients with chronic skin conditions.


  1. FDA approvesArcutis’ ZORYVE (roflumilast) cream 0.3% for the treatment of psoriasis in children ages 6 to 11. Arcutis Biotherapeutics. News release. October 6, 2023. Accessed October 6, 2023. https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-03-treatment
  2. Papp K, Lebwohl M, Chih-ho Hong, H, et al. Efficacy and safety of roflumilast cream 0.3% in patients with chronic plaque psoriasis: pooled PASI and PASI-HD results from the DERMIS-1 and DERMIS-2 phase 3 Trials. Presented at the 2023 American Academy of Dermatology Annual Meeting. March 17-21, 2023; New Orleans, Louisiana.
  3. Arcutis submits roflumilast cream 0.15% supplemental new drug application to the FDA for the treatment of atopic dermatitis in adults and children ages 6 years and older. Arcutis Biotherapeutics. News release. September 12, 2023. Accessed October 6, 2023. https://www.arcutis.com/arcutis-submits-roflumilast-cream-0-15-supplemental-new-drug-application-to-the-fda-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-ages-6-years-and-older/
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