FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Infants Down to 3 Months

About this update from Arcutis Biotherapeutics, Inc.

WESTLAKE VILLAGE, Calif., July 08, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months. The FDA has set a PDUFA target action date of February 23, 2027. "Infants with atopic dermatitis are particularly vulnerable to burdensome symptoms such as intense itch and sleep disruption, which can impact the whole family. Managing these symptoms can be particularly challenging for parents and caregivers due to the very limited FDA-approved treatment options as well as concerns about the use of topical steroids on infants whose skin barrier and immune system are still developing," said Lawrence F. Eichenfield, MD, of Rady Children's Hospital San Diego and the University of California San Diego School of Medicine and an INTEGUMENT-INFANT clinical trial investigator. "There is a significant unmet need in this population for therapies that can be used anywhere on the body for any duration of time, including on sensitive areas such as the face and skin folds. If approved, ZORYVE cream 0.05% could provide clinicians and caregivers with an important new steroid-free treatment option that was specifically developed for infants and very young children." Atopic dermatitis is the most common form of eczema and often begins during infancy, contributing to significant burden for both infants and caregivers due to the chronic cycling of itching and scratching that can lead to discomfort and disruptions in sleep. "This sNDA acceptance underscores the gap in approved treatments for very young children with atopic dermatitis," said Frank Watanabe, president and CEO of Arcutis. "If approved, investigational ZORYVE cream 0.05% would be the first once-daily advanced targeted topical treatment for this especially vulnerable patient population and would provide a much-needed non-steroidal treatment option that effectively reduces symptoms of atopic dermatitis like itch quickly, and with a safe and well-tolerated profile. This expanded indication would further reinforce ZORYVE's potential to serve as a foundational treatment option for individuals with atopic dermatitis from infancy through adulthood."

View stock analysis, news, and events for Arcutis Biotherapeutics, Inc.