Arcutis Biotherapeutics Inc. (ARQT), a commercial-stage biopharmaceutical company focused on immuno-dermatology, announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05%.
The application seeks to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months.
Atopic dermatitis, commonly known as eczema, is a chronic inflammatory skin condition that causes redness, itching, and irritation. It often begins in infancy and can significantly affect sleep and quality of life for both children and caregivers.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027. The submission is supported by positive results from the Phase 2 open-label INTEGUMENT-INFANT study and Phase 1 open-label pharmacokinetic (PK) study.
Atopic dermatitis, the most common form of eczema, often begins in infancy and can cause intense itching and sleep disruption, and discomfort for both infants and caregivers. Current treatment options are limited, and concerns about topical steroid use in very young children remain significant.
Lawrence F. Eichenfield, MD, of Rady Children's Hospital San Diego and the University of California San Diego School of Medicine, noted that infants with atopic dermatitis face "burdensome symptoms such as intense itch and sleep disruption," and highlighted the unmet need for therapies that can be used safely on sensitive areas like the face and skin folds. He added that ZORYVE could become the first once-daily, advanced targeted topical treatment for infants, offering rapid itch relief with a safe and well-tolerated profile.
ARQT has traded between $13.69 and $31.77 over the past year. The stock closed Tuesday's trading at $27.67, up 6.14%. In pre-market trading, the stock is at $27.87, up 0.71%.
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