Arcutis Submits sNDA for Roflumilast Cream 0.05% to FDA for Patients Ages 2 to 5 with Atopic Dermatitis

Image Credit: © JHVEPhoto - stock.adobe.com

It was announced today that Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for roflumilast cream 0.05% (Zoryve).¹ This new indication is targeted for patients between the ages of 2 and 5 for the treatment of mild to moderate atopic dermatitis (AD). Pediatric patients saw a rapid reduction in itch and a meaningful overall clearance of disease.

“When choosing a therapy for very young children living with AD, healthcare 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,” Rocco Serrao, MD, FAAD, of DOCS Dermatology and INTEGUMENT-PED and INTEGUMENT-OLE investigator, said in a statement. “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 submission to the FDA is supported by positive results from the pivotal phase 3, vehicle-controlled, INTEGUMENT-PED trial, as well as a long-term extension study and a phase 1 pharmacokinetic study. The INTEGUMENT-PED research included 652 children aged 2 to 5 with a mean AD body surface area of 22% and a range between 3% and 82%. Compared to the 10.7% of children treated with vehicle, 25.4% of patients saw a 2-grade improvement from baseline and achieved a score of “clear” or “almost clear” at week 4, according to the validated Investigator Global Assessment – Atopic Dermatitis scale (p < 0.0001). Some significant improvements were seen as early as week 1, with all secondary endpoints being met. Additionally, 35.3% of participants with a baseline Worst Itch Numeric Score of ≥ 4 achieved a 4-point reduction in the 4th week, compared to 18.0% of vehicle-treated children (nominal p = 0.0002).

Overall, the once-daily, phosphodiesterase 4 (PDE4) inhibitor was well-tolerated, with a safety profile that was consistent in adult and older pediatric patients treated with roflumilast cream 0.15% with mild to moderate AD. The most frequent adverse effects were upper respiratory tract infection, diarrhea, and vomiting.

The submission is also supported by data from the open-label, INTEGUMENT-OLE extension study, in which 562 pediatric patients were treated for up to 52 weeks. Roflumilast cream 0.15% is currently approved by the FDA for the treatment of mild to moderate AD in patients 6 years of age and older. The 0.3% cream version is also FDA-approved for plaque psoriasis treatment.

Frank Watanabe, president and CEO of Arcutis, said in a press release, “Parents, caregivers, and healthcare professionals need to feel confident in their treatment plan. Our clinical development program for ZORYVE reinforces the well-established efficacy, safety, and tolerability profile of roflumilast cream, which was designed to deliver the drug without disrupting the skin barrier or using sensitizing excipients and irritants. This lower concentration of roflumilast cream was intentionally formulated for the needs of younger children with AD and demonstrates our commitment to serving this vulnerable patient population. We look forward to the opportunity to offer ZORYVE cream 0.05%, if approved, as a new topical therapy for the 1.8 million children between the ages of 2 to 5 with AD and their families.”¹

Reference

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. News release. Arcutis Biotherapeutics, Inc. December 16, 2024. Accessed December 16, 2024. https://www.globenewswire.com/news-release/2024/12/16/2997469/0/en/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.html