FDA expands approval of ZORYVE (roflumilast) cream 0.3% for plaque psoriasis in children as young as 2, offering the first once‑daily, steroid‑free topical option for long‑term use across all body areas.
Written By: Mayuresh Salvi, PharmD
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has expanded the indication for ZORYVE (roflumilast) cream 0.3%, approving the once-daily topical phosphodiesterase-4 (PDE4) inhibitor for the treatment of plaque psoriasis, including intertriginous areas, in children as young as 2 years. The supplemental New Drug Application (sNDA) approval extends the therapy’s previous pediatric indication from age 6 years to age 2, making ZORYVE the first once-daily, steroid-free topical treatment approved for this population.
The latest approval marks the seventh FDA approval for the ZORYVE franchise within four years and provides clinicians with a long-term topical treatment option that can be used safely across all body areas without restrictions on treatment duration.
Addressing an Unmet Need in Pediatric Plaque Psoriasis
Plaque psoriasis is a chronic immune-mediated inflammatory skin disease that often begins during childhood and may persist throughout life. In young children, lesions frequently affect sensitive areas such as the face and skin folds, where prolonged use of topical corticosteroids is generally discouraged because of safety concerns.
Roflumilast is a selective PDE4 inhibitor that suppresses the production of pro-inflammatory mediators involved in psoriasis pathogenesis. By reducing inflammatory signaling within the skin, the therapy improves disease activity while avoiding corticosteroid-associated limitations. Its once-daily, steroid-free formulation supports long-term management, particularly in pediatric patients requiring sustained treatment.
Clinical Data Supported Expanded Pediatric Approval
The FDA based its decision on findings from the open-label MUSE study (ARQ-151-216, NCT04746911), which evaluated the pharmacokinetics, systemic exposure, safety, tolerability, and exploratory efficacy of ZORYVE cream 0.3% in children aged 2 to 5 years with plaque psoriasis involving at least 2% body surface area.
Long-term safety evidence came from the ARQ-151-306 open-label extension study (NCT04286607), which followed children aged 2 to 5 years for up to 24 weeks of treatment. The study demonstrated safety, tolerability, and efficacy findings that were generally consistent with those reported in the pivotal DERMIS-1 and DERMIS-2 Phase 3 trials conducted in adolescents and adults.
Investigators reported that the treatment remained well tolerated and produced clinical improvements comparable to those previously observed in older patient populations.
Expanding Long-Term Treatment Options for Young Children
Pediatric dermatologist and clinical trial investigator Lisa Swanson, MD, noted that young children with plaque psoriasis often develop disease in sensitive anatomical regions where long-term corticosteroid use is not recommended. She said the clinical studies showed consistent efficacy and favorable tolerability in children as young as two years, providing physicians with a topical therapy suitable for prolonged use anywhere on the body.
Frank Watanabe, President and Chief Executive Officer of Arcutis Biotherapeutics, said the approval addresses a longstanding treatment gap for children younger than six years who previously had few appropriate long-term therapeutic options. He added that the latest approval reflects the company’s continued expansion of the ZORYVE portfolio across inflammatory skin diseases.
Commercial Availability
ZORYVE cream 0.3% is immediately available through U.S. dermatology pharmacy and wholesaler channels. Arcutis continues to support patient access through the ZORYVE Direct Program, which provides insurance navigation, copay assistance for eligible commercially insured patients, and adherence support. The company’s Arcutis Cares program also offers the therapy at no cost for eligible uninsured and underinsured patients.
With this expanded pediatric indication, ZORYVE further strengthens its position as a non-steroidal topical treatment option across multiple inflammatory dermatologic diseases while broadening access to younger children with chronic plaque psoriasis.
What This Means for Patients
This approval gives children as young as 2 years with plaque psoriasis access to a once-daily, steroid-free treatment. ZORYVE cream can be used on any part of the body, including sensitive skin areas, without restrictions on how long it can be used. This provides patients, parents, and healthcare providers with a safe and effective long-term treatment option for managing plaque psoriasis.
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About the Writer
Mayuresh Sunil Salvi (Linkedin) is a PharmD professional and healthcare writer with a strong interest in pharmacovigilance, drug safety, and emerging medical research. He is passionate about exploring new drug discoveries, clinical research, and advances in evidence-based medicine. His interests also include ward rounds, prescription audits, and treatment analysis to support rational pharmacotherapy and improved patient care.