WESTLAKE VILLAGE, Calif., June 29, 2026
Arcutis Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) expanding the indication for ZORYVE® (roflumilast) cream 0.3% to treat plaque psoriasis, including intertriginous areas, in children as young as two years of age. The approval makes ZORYVE cream 0.3% the first once-daily, steroid-free topical therapy approved for pediatric plaque psoriasis patients aged 2 years and older. The topical PDE4 inhibitor is approved for use anywhere on the body, including sensitive skin areas such as the face and skin folds, with no restrictions on duration of use, providing an important long-term treatment option for young children living with this chronic inflammatory skin disease.
FDA Decision Backed by Pediatric Clinical Study Data
The expanded pediatric approval is supported by positive results from the MUSE (ARQ-151-216) study, a four-week open-label clinical trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of ZORYVE cream 0.3% in children aged 2 to 5 years with plaque psoriasis. Additional long-term evidence came from the ARQ-151-306 extension study, which followed patients for up to 24 weeks. The results demonstrated that the safety and efficacy profile of ZORYVE in young children was consistent with findings from the pivotal DERMIS-1 and DERMIS-2 Phase 3 trials conducted in adolescents and adults. Clinical investigators noted that the therapy offers an effective alternative to topical corticosteroids, which are generally not recommended for prolonged use or application on sensitive skin areas in pediatric patients.
New Treatment Option Addresses Significant Pediatric Need
Plaque psoriasis is a chronic immune-mediated inflammatory skin disease that often begins during childhood and can persist throughout life, causing itching, redness, scaling, skin irritation, and significant quality-of-life challenges for both children and caregivers. Until now, treatment options for children younger than six years have remained extremely limited, particularly therapies suitable for long-term continuous use. ZORYVE cream 0.3%, a selective phosphodiesterase-4 (PDE4) inhibitor, directly targets inflammatory pathways responsible for psoriasis while avoiding the long-term safety concerns associated with topical steroids. According to Arcutis, the therapy is already widely available through major wholesalers and dermatology pharmacies, supported by the company’s ZORYVE Direct Program and Arcutis Cares™ patient assistance initiatives designed to improve treatment access and affordability.
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Seventh FDA Approval Strengthens Arcutis Dermatology Portfolio
The latest approval represents the seventh FDA approval across the ZORYVE franchise in just four years, highlighting Arcutis’ expanding leadership in medical dermatology. ZORYVE has become one of the leading branded topical therapies for inflammatory skin diseases, with approved indications spanning plaque psoriasis, atopic dermatitis, and seborrheic dermatitis across multiple age groups and formulations. Company executives stated that expanding access to children as young as two years reflects Arcutis’ commitment to delivering innovative therapies for underserved pediatric populations. The approval further reinforces the company’s strategy of developing targeted, steroid-free dermatology treatments capable of addressing long-term disease management while improving quality of life for patients living with chronic inflammatory skin disorders.
Source: Arcutis Biotherapeutics, press release
