Atopic Dermatitis

The FDA has extended the review of ruxolitinib for atopic dermatitis in children 2 to 11 years to September 2025 to evaluate new CMC data.

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The phase 2 trial will be 4 weeks and evaluate investigational, once-daily roflumilast cream 0.05% in infants 3 months to less than 2 years of age.

Results at 24 weeks revealed that 76% of individuals achieved a 75% or more improvement in overall disease severity (EASI-75), trial's primary endpoint.

View our Q1 2025 recap of standout pediatric news from FDA regulatory updates, clinical trial results, and expert commentary.

Peter Lio, MD, offers thoughts on recent atopic dermatitis data reported for lebrikizumab.

The newest tapinarof results were presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting.

Lebrikizumab improves itch, sleep interference, and skin pain in atopic dermatitis patients previously treated with dupilumab, offering a new treatment option.

The application is for children aged 2 to 5 years with mild-to-moderate atopic dermatitis.

Nearly 40% of children treated with roflumilast cream 0.05% achieved a 75% improvement in EASI-75.

The investigational biologic targets the interleukin-2 receptor complex in the body in order to stimulate proliferation of inhibitory immune cells.

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The past year saw a number of approvals adding to the toolbox for atopic dermatitis, including new formulations that work in new mechanisms.

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From new topical dermatology treatments for atopic dermatitis to the first nasal spray to treat type 1 allergic reactions, these are our top FDA approvals of 2024.

Arcutis seeks FDA approval for roflumilast cream 0.05% (ZORVYE) to treat mild to moderate atopic dermatitis in children 2 to 5 years.

According to Galderma, approval is based on positive results from the phase 3 ARCADIA clinical trial program.

"I really hope this becomes a first-line agent that people are comfortable prescribing whether they are in dermatology, pediatric dermatology, or primary care."

In the study through 76 weeks, no new risks were observed with once-daily upadacitinib (15 mg or 30 mg).

The submission to treat PsO is for children aged 6 years and up while the jPsA submission is to treat children aged 5 years and older.

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The federal agency has not raised any concerns regarding safety and efficacy of tapinarof cream, 1%.

In all, 51.9% of patients entered with or achieved complete disease clearance at least once during the 48-week study.

A recent study presented at the American Academy of Pediatrics 2024 National Conference & Exhibition, sheds light on the connection between skin conditions and sleep disturbances in infants and toddlers, highlighting itchy skin as a significant factor, even in the absence of atopic

Eric Simpson, MD, MCR, FAAD, lead author of a recently-published article highlighting roflumilast cream 0.15%, joined us for a Q+A interview.

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The indication is supported by trial data showing three-fourths of successfully treated patients maintained clear skin through 1 year of a lebrikizumab regimen.

Efficacy of roflumilast cream 0.05% improved over time among children aged 2 to 5 years with mild to moderate atopic dermatitis.

Details of newly FDA-approved roflumilast cream 0.15% for AD in pediatric patients, plus insight and commentary from Lawrence Eichenfield, MD.

The decision target action date was July 7, 2024. At this time, there is no indication from the federal agency to extend the date further.