FDA Accepts Arcutis' ZORYVE Cream Application for Young Children with Atopic Dermatitis

Arcutis Biotherapeutics, Inc., a company at the forefront of biopharmaceutical developments in dermatology, has announced a significant milestone in the advancement of a new treatment for atopic dermatitis (AD) in young children. The U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05%. This topical treatment, a next-generation phosphodiesterase-4 (PDE4) inhibitor, is intended for children aged 2 to 5 years and is designed to address mild to moderate cases of AD. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for this application as October 13, 2025.

Mercedes E. Gonzalez, MD, serving as the medical director of Pediatric Skin Research, LLC, and an investigator in the INTEGUMENT PED clinical trial, has expressed optimism about ZORYVE cream's efficacy and safety, as observed in clinical trials. These trials demonstrated significant positive outcomes in treating AD among the young demographic. Dr. Gonzalez emphasized the cream's potential to improve quality of life for both affected children and their caregivers, citing the chronic nature of AD and its impact on sensitive areas like the face and neck, which often lead to persistent itching and discomfort.

AD is a chronic inflammatory skin disorder with a genetic predisposition, characterized by red, itchy rashes that can affect any part of the body. The condition varies in its manifestation across different age groups, from infants to adults. Current topical treatments for young children with AD often require compromises between efficacy, safety, and tolerability. The investigational ZORYVE cream 0.05% has shown promising results in alleviating symptoms without compromising on these fronts.

Frank Watanabe, President and CEO of Arcutis, highlighted the company's commitment to improving treatment options for immune-mediated dermatological diseases. He noted that ZORYVE cream 0.05% offers a promising alternative to traditional steroid treatments. The drug's efficacy in relieving AD symptoms, alongside a strong safety profile, positions it as a potential game-changer for the 1.8 million young children in the United States suffering from AD.

The application for ZORYVE cream 0.05% is backed by extensive research, including the pivotal INTEGUMENT-PED Phase 3 trial, a long-term extension study lasting up to 52 weeks, and a Phase 1 pharmacokinetic study. The Phase 3 trial included 652 children aged 2 to 5 years, with varied Body Surface Area (BSA) involvement. Notably, significant improvements were observed as early as the first week, with 25.4% of children treated with the cream achieving 'Clear' or 'Almost Clear' ratings by Week 4, compared to only 10.7% in the placebo group. Additionally, the cream effectively reduced itch severity, with over a third of participants experiencing a four-point reduction in their itch score by the fourth week.

Throughout the trials, ZORYVE cream 0.05% demonstrated a favorable safety profile, with adverse events being infrequent and consistent with those seen in older demographics using ZORYVE cream 0.15%.

The active ingredient in ZORYVE, roflumilast, is a PDE4 inhibitor. By targeting this intracellular enzyme, the cream modulates inflammatory processes, thereby reducing the symptoms of dermatological conditions. ZORYVE cream 0.3% is already approved for treating plaque psoriasis in patients aged six years and older, and ZORYVE cream 0.15% is approved for mild to moderate AD in the same age group.

Arcutis Biotherapeutics continues to focus on pioneering therapies for dermatological conditions through its comprehensive dermatology development platform. The company aims to address unmet needs within the field of immuno-dermatology, with a growing portfolio that includes several FDA-approved products.