Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months

Submission supported by data from INTEGUMENT-INFANT Phase 2 open-label study in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis Once-daily ZORYVE cream was well tolerated with a safety profile consistent with that in older children and adults Atopic dermatitis impacts 1 million children under the age of 2 in the United States Only one other FDA-approved topical non-steroidal anti-inflammatory agent available for this vulnerable population WESTLAKE VILLAGE, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT ), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication for ZORYVE ® (roflumilast) cream 0.05% to include the topical treatment of mild to moderate atopic dermatitis in infants down to 3 months. "Atopic dermatitis often begins within the first year of life, yet treatment options for infants are extremely limited. Parents and caregivers are often faced with difficult decisions around managing these symptoms, including concerns about the long-term use of topical steroids," said Mercedes E. Gonzalez, MD, medical director of Pediatric Skin Research, LLC and INTEGUMENT-INFANT clinical trial investigator. "Because their immune system and skin barrier are still developing, infants are particularly vulnerable to the burdensome symptoms of atopic dermatitis, including visible disease and intense itch that can disrupt sleep and significantly impact both infants and their caregivers. Safe and effective long-term therapies suitable for use anywhere on the body, including sensitive regions such as the face and skin folds, remain an important unmet need for infants with atopic dermatitis. If approved, ZORYVE cream 0.05% could offer a much-needed, non-steroidal treatment option developed specifically for very young children, including infants." Atopic dermatitis is the most common form of eczema and frequently presents during infancy, contributing to significant child and caregiver burden and impaired quality of life. In infants, atopic dermatitis can have more widespread presentation on the body and infants demonstrate a higher body surface area-to-body mass ratio, which may increase the risk of side effects from topical treatment. "This sNDA submission represents an important milestone in our effort to expand treatment options for infants as young as 3 months living with atopic dermatitis, an age group with very limited treatment options today," said Frank Watanabe, president and CEO of Arcutis. "If approved, investigational ZORYVE cream 0.05% could offer an effective and well-tolerated treatment option suitable for long-term use, helping infants and their families maintain clear skin and limit cumulative topical steroid exposure. This potential age expansion supports our strategy to broaden ZORYVE's reach and reinforces its role as a foundational therapy across age groups." The sNDA is supported by positive results from a Phase 1 open-label pharmacokinetic (PK) trial and a Phase 2 open-label trial (INTEGUMENT-INFANT), both of which evaluated once-daily ZORYVE cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. The Phase 1 study enrolled 19 infants and demonstrated PK, safety and efficacy profiles over four weeks that were consistent with those from prior pediatric atopic dermatitis studies in older children. The INTEGUMENT-INFANT study enrolled 101 infants and assessed safety, tolerability, and efficacy over four weeks, and in this study, ZORYVE ... Full story available on Benzinga.com