FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5

About this update from Arcutis Biotherapeutics, Inc.

ZORYVE cream 0.05% provides rapid and effective relief of mild to moderate atopic dermatitis in children ages 2 to 5 and is safe and well tolerated Once-daily, steroid-free cream can be used anywhere on the body for any duration About 1.8 million children ages 2 to 5 with atopic dermatitis are topically treated in the U.S. Sixth FDA approval for ZORYVE in just over three years Commercial product expected to be available by the end of October 2025 WESTLAKE VILLAGE, Calif. , Oct. 06, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company dedicated to developing meaningful innovations in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age. Once-daily ZORYVE cream 0.05% provides rapid and significant clearance of atopic dermatitis anywhere on the body and offers clinicians, parents, and caregivers of children ages 2 to 5 an alternative to steroids that can be used for any duration. “It is essential to have safe and effective treatments for children, who are often diagnosed with atopic dermatitis at a young age and can live with the condition across their lifetime. Young children often experience widespread disease, affecting large portions of their skin. Although topical steroids have been the standard treatment for years, they are not appropriate for long-term use,” said Lawrence F. Eichenfield , MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and INTEGUMENT study investigator. "In clinical trials, ZORYVE cream 0.05% rapidly improved the severity and extent of eczema (atopic dermatitis) signs and symptoms, with approximately 40% of children achieving a 75% improvement from baseline as measured by EASI , and more than one-third (35%) achieving a clinically meaningful improvement in itch intensity, both in only four weeks. With this approval, healthcare providers and families have an effective new treatment option for young children with atopic dermatitis.” In the United States , approximately 1.8 million children between the ages of 2 to 5 with atopic dermatitis are treated with a topical product. Itch is one of the most burdensome symptoms of the disease, and children can be caught in an itch-scratch cycle that can worsen their symptoms. “Young children are particularly vulnerable to the bothersome symptoms of atopic dermatitis, because their immune system and skin barrier are less developed than those of older children and adults,” said Korey Capozza , MPH, founder and executive director at Global Parents of Eczema Research . “This condition doesn’t just affect the child’s skin — it can affect the whole family by causing sleep disruption, emotional distress, and social isolation. We are excited to see advancements in treatment options for the millions of children and families who are impacted by this disease.” “ZORYVE cream was intentionally formulated to address the critical unmet need in atopic dermatitis care, and it provides a safe, effective alternative to steroid treatments, targeting the underlying inflammation that drives disease activity. Notably, ZORYVE does not include ingredients known to compromise the skin barrier, which is especially important for young children with atopic dermatitis,” said Frank Watanabe , president and chief executive officer of Arcutis. “ZORYVE provides patients and their families with a treatment option for long-term, continuous use, helping maintain clear skin and limiting cumulative topical steroid exposure.” “Seeing our daughter, Kylie, struggle with atopic dermatitis for so long was heartbreaking, but it also took a toll on the whole family. Kylie was uncomfortable, especially at night, which kept the family up and wore on our energy. I felt helpless,” said Melissa Walters , caregiver of a child who participated in the INTEGUMENT-PED and INTEGUMENT-OLE studies. “It was frustrating to feel like we were stuck in a cycle of short-term fixes. We enrolled Kylie in the ZORYVE cream clinical trial when she was 2, which resulted in her skin improving and becoming clear. I want to share our story to empower other parents to advocate for their children and talk to their healthcare provider about treatment options that can be used long term.” The latest approval of ZORYVE cream 0.05% represents the sixth FDA approval for the ZORYVE portfolio in just over three years. Arcutis intends to make ZORYVE cream 0.05% widely available via key wholesaler and pharmacy channels as a new treatment option by the end of October 2025 . The Company is dedicated to ensuring predictable access for the ZORYVE portfolio of products, with one simple copay card and fulfillment process. The ZORYVE® Direct Program helps patients access their prescribed Arcutis medication. Specifically, this patient support program helps those who have been prescribed ZORYVE to navigate the payer process, assists patients with adherence, and includes the ZORYVE Direct Savings Card Program, which can help reduce out-of-pocket costs for eligible commercially insured patients.† Arcutis will also continue to offer the Arcutis Cares™ patient assistance program (PAP) that provides ZORYVE at no cost for financially eligible patients who are uninsured or underinsured.‡ For more information on ZORYVE, including full Prescribing Information, please visit http://www.zoryvehcp.com/ . A Media Snippet accompanying this announcement is available by clicking on this link. Clinical Data The FDA approval of ZORYVE cream 0.05% is based on results from the INTEGUMENT-PED Phase 3 trial (INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis), the INTEGUMENT-OLE long-term extension study, and a Phase 1 pharmacokinetic study. In clinical trials, ZORYVE demonstrated rapid clearance of atopic dermatitis, with positive results across all efficacy endpoints, and was safe and well tolerated. INTEGUMENT-PED was a randomized, double-blind, vehicle-controlled, parallel-group study, that evaluated ZORYVE cream or vehicle once-daily for 4 weeks in 652 children ages 2 to 5 years (n=437 treated with ZORYVE cream, n=215 vehicle). INTEGUMENT-OLE was a Phase 3, multicenter, open-label extension study of the long-term safety and efficacy of ZORYVE cream 0.15% in adults and children ages 6 years and older with atopic dermatitis and ZORYVE cream 0.05% in children ages 2 to 5 years with atopic dermatitis. A total of 658 children and adults from INTEGUMENT-1 and -2 and 562 children from INTEGUMENT-PED enrolled in the INTEGUMENT-OLE study. In the INTEGUMENT-PED trial, ZORYVE demonstrated rapid disease clearance, with data showing significant improvements as early as Week 1. At Week 4, 25.4% of children treated with ZORYVE cream 0.05% achieved vIGA-AD Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘Clear’ or ‘Almost Clear’, plus a 2-grade improvement from baseline, compared to 10.7% of children treated with vehicle (P

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