Roflumilast 0.05% sNDA submitted to FDA for atopic dermatitis in children 2 to 5 years

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Arcutis Biotherapeutics has submitted a supplemental new drug application (sNDA) to the FDA for roflumilast cream 0.05% (ZORYVE), a once-daily topical treatment for mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years.¹

Roflumilast cream 0.05% is a topical PDE4 inhibitor. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases the production of anti-inflammatory mediators.¹

Rocco Serrao, MD, FAAD, of DOCS Dermatology and an investigator in the INTEGUMENT-PED and INTEGUMENT-OLE studies, highlighted the importance of safe and effective options for pediatric AD patients: “When choosing a therapy for very young children living with AD, health care providers and caregivers have to account for unique considerations for pediatric patients, including sensitive skin, and select a medication that is appropriate for long-term use by a child with a chronic skin condition. Data from the pivotal trial demonstrated that roflumilast cream 0.05% provided consistent and rapid relief, and was well-tolerated.”¹

He added, “If approved, roflumilast cream 0.05% would offer a new topical option with the potential to advance the standard of care for these young patients, offering fast relief to the children and their families from the onerous symptoms of AD.”¹

The sNDA is backed by positive data from multiple studies, including the INTEGUMENT-PED phase 3 trial involving 652 children with a mean AD Body Surface Area (BSA) of 22%.¹

Results demonstrated that 25.4% of children treated with roflumilast cream achieved vIGA-AD Success by week 4, compared to 10.7% in the vehicle-treated group (P<0.0001). Additionally, improvements were seen as early as week 1, with 35.3% of children experiencing significant itch reduction by week 4.¹

Safety data showed that roflumilast cream 0.05% was well-tolerated. Adverse events included upper respiratory tract infection, diarrhea, and vomiting, which occurred at rates consistent with prior studies.¹

Long-term safety was also demonstrated in the INTEGUMENT-OLE open-label extension study, which involved 562 patients treated for up to 52 weeks.²

As reported by Contemporary Pediatrics, 71.9% of participants who rolled over from the roflumilast treatment arm in INTEGUMENT-PED achieved a 75% improvement from baseline Eczema Area and Severity Index (EASI-75) after 56 weeks. In addition, 53.8% of participants who rolled over achieved a validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) success, defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline, at 56 weeks, according to Arcutis.²

Roflumilast cream 0.05% has already been approved by the FDA in higher concentrations for plaque psoriasis and AD in older patients. Pending FDA approval, roflumilast cream 0.05% may soon offer an innovative solution for children and families grappling with AD’s challenges.¹

References:

1. Arcutis Submits ZORYVE® (roflumilast) Cream 0.05% Supplemental New Drug Application to the FDA for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis. Biospace. December 16, 2024. Accessed December 16, 2024. https://www.biospace.com/press-releases/arcutis-submits-zoryve-roflumilast-cream-0-05-supplemental-new-drug-application-to-the-fda-for-the-treatment-of-children-aged-2-to-5-with-mild-to-moderate-atopic-dermatitis

2. Arcutis announces positive long-term results of roflumilast cream 0.05% show durable and improved efficacy over time and favorable safety profile in treatment of children aged 2 to 5 with mild to moderate atopic dermatitis. Arcutis Biotherapeutics. August 28, 2024. Accessed December 16, 2024. https://www.arcutis.com/arcutis-announces-positive-long-term-results-of-roflumilast-cream-0-05-show-durable-and-improved-efficacy-over-time-and-favorable-safety-profile-in-treatment-of-children-aged-2-to-5-with-mild-to-moder/