April 3rd 2025
View our Q1 2025 recap of standout pediatric news from FDA regulatory updates, clinical trial results, and expert commentary.
Roflumilast cream 0.15% for atopic dermatitis demonstrates strong individual patient response data
January 16th 2024According to new pooled individual patient responses, roflumilast cream 0.15% treatment led nearly 92% of individuals to achieve a measurable improvement in the Eczema Area and Severity Index.
New topline phase 3 data for tapinarof cream 1% to treat AD in children
January 11th 2024New interim data from the on-going, long-term extension ADORING 3 study and from an integrated analysis of the entire ADORING development program revealed efficacy and safety using tapinarof cream 1% continued beyond 8 weeks of treatment.
Worsening severity of AD in children associated with increased comorbidity onset risk
November 27th 2023Of patients in the atopic dermatitis (AD) cohort, 36.6% developed at least 1 comorbidity amid follow-up compared to 28.5% in the non-AD reference cohort, investigators of a Sweden, nationwide, population-based cohort study found.
Lebrikizumab improves AD symptoms for adolescents inadequately controlled with cyclosporine
October 17th 2023Of the patients that responded to lebrikizumab at week 16 in the phase 3 trials ADvocate 1 and ADvocate 2, 84% achieved a clinically meaningful response in at least 1 domain of the disease (mild signs, symptoms, or quality of life impact) at 52 weeks.
Tapinarof cream 1% reduces itch as early as 24 hours after application for pediatric AD
October 13th 2023A rapid reduction in pruritis as early as 24 hours after first application was announced as new positive data from a pair of identical, phase 3 studies of tapinarof cream 1% in children as young as 2 years and adults with atopic dermatitis (AD).
Arcutis submits roflumilast 0.15% sNDA for AD in children 6 years and up
September 21st 2023Positive topline results from a pair of identical phase 3 trials support the submission of a supplemental New Drug Application to the FDA for Arcutis Biotherapeutics’ roflumilast cream 0.15%, a once-daily topical to treat mild to moderate atopic dermatitis (AD) in children 6 years or older.
Roflumilast cream 0.05% safe, effective for children aged 2 to 5 years with atopic dermatitis
September 20th 2023Based on recent positive phase 3 results, Arcutis Biotherapeutics,. intends to submit a supplemental New Drug Application with the FDA for roflumilast cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2 to 5 years.
Tapinarof cream 1% demonstrates positive topline results for treating pediatric AD
May 16th 2023The once-daily topical cream for the treatment of atopic dermatitis (AD) has demonstrated positive topline results in 2 phase 3 studies in adults and children aged 2 years and up. According to Dermavant, a supplemental new drug application (sNDA) filed with the FDA is anticipated in Q1 of 2024.
Study finds no significant link between atopic dermatitis severity scores, peanut sensitivity
November 29th 2022Research suggested no significant relationship between peanut sensitivity and AD severity as measured by two scores, although the study was acknowledged to have a smaller population due to pandemic restrictions.
Roflumilast cream safe, effective for atopic dermatitis in children 6 years and up
November 16th 2022Recently announced data from the INTEGUMENT-1 phase 3 clinical trial demonstrated positive safety and efficacy results for atopic dermatitis patients 6 years and older treated with roflumilast cream (Arcutis Biotherapeutics).
Frequent allergies in pediatric atopic dermatitis, eosinophilic esophagitis patients in Puerto Rico
November 16th 2022New data presented at ACAAI 2022 observed various trends in allergies associated with eczema and eosinophilic esophagitis, comparing observed data with that of patients in the United States.