Arcutis' ZORYVE® (roflumilast) Cream Receives Strong Recommendation in American Academy of Dermatology First-Ever Pediatric Atopic Dermatitis Guidelines

Strong recommendation with high certainty of clinical evidence underscores proven efficacy, safety, and tolerability of ZORYVE cream as a steroid-free topical phosphodiesterase type 4 (PDE4) inhibitor Atopic dermatitis affects approximately 9.6 million children in the United States WESTLAKE VILLAGE, Calif., April 22, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT ), a commercial-stage biopharmaceutical company dedicated to developing meaningful innovations in immuno-dermatology, today announced that ZORYVE® (roflumilast) cream has received a strong recommendation, with high certainty of clinical evidence, in the American Academy of Dermatology (AAD) clinical practice guidelines for the management of pediatric atopic dermatitis. The AAD's evidence-based guidelines recommend the use of ZORYVE cream 0.05% for children aged 2-5 years and ZORYVE cream 0.15% for children aged 6 years and older with mild to moderate atopic dermatitis, recognizing its efficacy, safety, and tolerability. The recommendation reinforces ZORYVE's ability to deliver clinically meaningful improvements in disease severity and itch with very low rates of treatment discontinuation, offering an effective topical suitable for long-term use anywhere on the body in both children and adolescents. In clinical trials, the most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for pediatric patients 2 to 5 years of age with atopic dermatitis were upper respiratory tract infection, diarrhea, vomiting, rhinitis, conjunctivitis, and headache. The most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for patients 6 years of age or older with atopic dermatitis were headache, nausea, application site pain, diarrhea, and vomiting. "The AAD's strong recommendation for ZORYVE cream, building on its previous strong recommendation in adults, reflects the high certainty of evidence supporting its efficacy, low rates of treatment discontinuation, and favorable tolerability in pediatric patients. These evidence-based recommendations help clinicians make informed treatment decisions for children, adolescents, and their caregivers managing this chronic condition and reinforce the value of ZORYVE as a topical PDE4 inhibitor," said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. "Since atopic dermatitis is a lifelong condition that often begins in childhood, when the immune system and skin barrier are still developing, it is critical to have therapies that balance efficacy with long-term safety and tolerability. ZORYVE does not include ingredients or irritants known to compromise the skin barrier, which is especially important in these age groups." The pediatric guidelines were developed by a multidisciplinary workgroup using a systematic evidence review and the GRADE framework to assess certainty of evidence and strength of ... Full story available on Benzinga.com