Arcutis Poised to Fill Unmet Need with Pediatric Psoriasis Treatment

NEW YORK, NY – November 17, 2025 – Arcutis Biotherapeutics, Inc. announced today that the Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.3% to expand its use to children aged 2-5 with plaque psoriasis. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026, putting the company on track to potentially address a critical unmet need in pediatric dermatological care.

Addressing a Significant Gap in Pediatric Psoriasis Treatment

Plaque psoriasis, a chronic autoimmune condition causing raised, scaly patches on the skin, affects approximately 9 million people in the United States. While manageable in many adults, the condition presents unique challenges in young children, particularly those under the age of six. Existing treatment options are often limited, and many conventional approaches carry risks or are not ideally suited for sensitive pediatric skin.

“There's a real lack of approved therapies specifically designed for very young children with psoriasis,” explains a leading pediatric dermatologist. “Many physicians rely on off-label use of existing medications or steroids, which aren’t ideal for long-term management, especially in areas like the face and skin folds.”

The current standard of care often involves topical steroids, which, while effective, can have undesirable side effects with prolonged use, including skin thinning and changes in pigmentation. Systemic treatments and biologics, while effective for more severe cases, are typically reserved for older children and carry their own set of risks and monitoring requirements. This leaves a significant gap in care for young children with mild to moderate psoriasis, for whom safe, effective, and convenient topical options are limited.

ZORYVE: A Novel Approach to Pediatric Psoriasis

ZORYVE is a topical phosphodiesterase 4 (PDE4) inhibitor, a class of drugs that modulates the immune response in the skin. Currently approved for adults and children aged six and older, ZORYVE offers a steroid-free alternative for managing plaque psoriasis. The sNDA seeks to expand its label to include children aged 2-5, potentially offering the first dedicated topical treatment for this vulnerable age group.

The application is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study and a long-term open-label study. These trials demonstrated acceptable systemic exposure levels and a favorable safety profile in young children, indicating that ZORYVE can be used safely and effectively without causing significant side effects. The clinical trials show consistent results across age groups, suggesting that the medication can be a viable solution for various stages of the condition.

Arcutis Biotherapeutics is building on previous successes in the market. The company's existing ZORYVE products have already received recognition from organizations like the National Psoriasis Foundation, validating its commitment to quality and innovation. ZORYVE’s steroid-free formulation is proving to be a significant selling point as concerns about steroid usage continue to grow among both medical professionals and patients.

Arcutis’s Growth Strategy and Market Potential

The potential expansion of ZORYVE's label represents a significant growth opportunity for Arcutis Biotherapeutics. The company has demonstrated strong financial performance in recent quarters, with revenue and profitability increasing substantially. In the third quarter of 2025, Arcutis reported total revenue of $99.2 million, a 122% increase compared to the same period last year. This growth is largely attributed to the success of ZORYVE, as well as the company's commitment to innovation and its expanding portfolio of dermatological products.

“Arcutis has strategically positioned itself as a key player in the immuno-dermatology space,” states a financial analyst. “Expanding ZORYVE’s label into the pediatric population is a logical next step, as it addresses a clear unmet need and taps into a new market segment.”

The market for pediatric psoriasis treatments is expected to grow in the coming years, driven by increasing awareness of the condition and the availability of more effective therapies. Arcutis is well-positioned to capitalize on this trend, with a strong pipeline of products and a proven track record of success. The company's commitment to research and development, combined with its strategic partnerships and acquisitions, will likely drive further growth in the years ahead. The current market cap of $2.97 - $3.07 billion USD suggests investor confidence in the company’s long-term viability.