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SNDA Submitted for Roflumilast Cream for the Treatment of Plaque Psoriasis Down to 2 Years


Arcutis Biotherapeutics' indication expansion is based on data from MUSE studies.

Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the expanded indication of roflumilast cream 0.3% (Zoryve) for the treatment of plaque psoriasis in pediatric patients aged 2 to 11 years old. The expanded indication is based on data from 2 recently completed 4-week Maximal Usage Systemic Exposure (MUSE) studies (NCT04655313; NCT04746911) in pediatric patients with plaque psoriasis. If FDA-approved, roflumilast cream will be the first steroid-free topical phosphodiesterase-4 (PDE4) inhibitor for pediatric patients with plaque psoriasis.

Roflumilast cream was approved in July of this year for patients with plaque psoriasis, aged 12 years or older. The approval was based on data from the pivotal DERMIS-1 and DERMIS-2 pivotal phase 3 studies. With the July 2022 approval, roflumilast cream was also the first and only topical PDE4 inhibitor approved for the treatment of plaque psoriasis in adolescents and adults in hard-to-treat areas such as knees and elbows, as well as sensitive areas such as the face, intertriginous areas, and genitalia. Pharmacokinetic, safety, tolerability, and efficacy data from the 2 MUSE studies are consistent with data from the DERMIS-1 and DERMIS-2 pivotal phase 3 trials.

Current treatment options for pediatric patients with plaque psoriasis are lacking, and Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis, is excited to see roflumilast cream expand the availability of an effective treatment for pediatric patients with plaque psoriasis.

Roflumilast cream demonstrated a favorable safety and tolerability profile in the pediatric population of the study, with minimal local site reactions. The non-greasy and moisturizing formulation spreads easily and is aesthetically pleasing to pediatric patients that may be irritated by greasy or thick formulation textures.


  1. Arcutis submits supplemental new drug application for zoryve (roflumilast) cream 0.3% for expanded indication for the treatment of plaque psoriasis in children down to 2 years of age. Arcutis Biotherapeutics. Published December 19, 2022. Accessed December 19, 2022. https://investors.arcutis.com/news-releases/news-release-details/arcutis-submits-supplemental-new-drug-application-zoryver
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