Arcutis Presents New Caregiver-Reported Outcomes Data Supporting ZORYVE® (roflumilast) Cream 0.05% for Mild to Moderate Atopic Dermatitis in Infants Down to 3 Months at the ACAAI Annual Scientific Meeting
Key Highlights
- ➤sNDA seeks ZORYVE 0.05% approval for infants aged 3 to 24 months
- ➤PDUFA target action date set for February 23, 2027
- ➤101-infant trial showed no serious or severe treatment-emergent adverse events
- ➤Caregivers reported itch improvement reaching 66.7% at four hours
- ➤Mean POEM scores fell from 14.5 baseline to 6.5 at Week 4
Expert Statements
Mark Boguniewicz, Professor, Department of Pediatrics, National Jewish Health and University of Colorado School of Medicine
“Managing atopic dermatitis in infants can be particularly challenging, especially given the lifelong, chronic nature of the disease and the fact that the skin barrier and immune system are still developing. Today, there are very limited approved treatment options for infants, especially steroid-free options, leaving healthcare providers and caregivers with too few options.”
Mark Boguniewicz, Professor, Department of Pediatrics, National Jewish Health and University of Colorado School of Medicine
“These new findings showed that alongside having a generally safe and well-tolerated profile, ZORYVE demonstrated improvements in the signs and symptoms of atopic dermatitis, as well as quality of life measurements, as reported by caregivers. These results underscore the importance of expanding treatment options to address the unique needs of this vulnerable population.”
Patrick Burnett, Chief Medical Officer of Arcutis
“These new caregiver-reported outcomes showing improvement in both symptoms and quality of life measures add to the growing body of clinical evidence supporting the potential of ZORYVE cream 0.05% to address a significant unmet need for infants with atopic dermatitis and their families.”
Patrick Burnett, Chief Medical Officer of Arcutis
“Together with previously reported results, these findings reinforce the potential of ZORYVE to provide a well-tolerated, steroid-free treatment option for managing the burdensome symptoms of atopic dermatitis that can begin in infancy. With our supplemental New Drug Application currently under FDA review, we look forward to the possibility of bringing this important new treatment option to infants as young as 3 months of age, if approved.”
* New INTEGUMENT-INFANT trial results demonstrate improvements in itch, reductions in symptoms, and improvements in quality of life for infants with atopic dermatitis and their families * Findings further support investigational ZORYVE cream 0.05% to help address unmet needs in infants aged 3 to <24 months * 60% of children develop atopic dermatitis symptoms within their first year of life WESTLAKE VILLAGE, Calif., Nov. 13, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new caregiver-reported outcomes data from the INTEGUMENT-INFANT trial supporting ZORYVE(®) (roflumilast) cream 0.05% in the treatment of infants with mild to moderate atopic dermatitis ages 3-24 months presented at the American College of Allergy, Asthma & Immunology's (ACAAI) Annual Scientific Meeting, taking place Nov. 12-16 in Phoenix, Arizona.
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