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The FDA has approved roflumilast cream 0.3% for the treatment of plaque psoriasis in children aged 2 years or older, the manufacturer announced in a press release.
Roflumilast cream 0.3% (Zoryve) was previously approved for individuals aged 6 years or older with plaque psoriasis for use anywhere on the body, including intertriginous areas.
The cream formulation of roflumilast, a phosphodiesterase 4 inhibitor applied once daily, was originally approved in 2022 for the treatment of psoriasis in patients aged 12 years or older, and the indication was extended to children aged 6-11 years in 2023.
The new approval is based on data from an open-label 4-week Maximal Usage Systemic Exposure (MUSE) study of children aged 2-5 years with plaque psoriasis with involvement of at least 2% of their body surface area, according to the manufacturer, Arcutis Biotherapeutics. The study evaluated safety, tolerability, exploratory efficacy, and pharmacokinetics. An open-label extension study evaluating long-term safety, tolerability, and efficacy of roflumilast cream 0.3% for up to 24 weeks of treatment in children ages 2-5 years provided “supportive long-term safety data,” according to the company.
Safety and efficacy results “were generally consistent” with those found in the phase 3 pivotal DERMIS-1 and DERMIS-2 studies in adolescents and adults, the company said in the release.
The most frequently reported adverse events related to roflumilast 0.3% cream in the DERMIS studies were diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection.
A foam formulation of 0.3% roflumilast is approved for treating plaque psoriasis on the scalp and body for patients aged 12 years or older and for seborrheic dermatitis in adult and pediatric patients aged 9 years or older. A 0.15% cream is indicated for the treatment of mild-to-moderate atopic dermatitis in patients aged 6 years or older, and a 0.05% cream was approved for treating mild-to-moderate atopic dermatitis in children aged 2-5 years in October 2025.
