FDA Accepts sNDA for ZORYVE Cream 0.05% to Treat Atopic Dermatitis in Infants – Arcutis Biotherapeutics

 Arcutis Biotherapeutics announced that the 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. 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.” – 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.

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. 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.” – Frank Watanabe, president and CEO of Arcutis.

The sNDA is supported by positive results from the Phase 2 open-label INTEGUMENT-INFANT study, as well as a Phase 1 open-label pharmacokinetic (PK) study, 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 INTEGUMENT-INFANT study enrolled 101 infants and assessed safety, tolerability, and exploratory efficacy over 4 weeks. The Phase 1 study enrolled 19 infants. Both studies demonstrated PK, safety, and efficacy profiles over 4 weeks that were consistent with those from prior atopic dermatitis studies in children 2 to 5 years of age treated with Zoryve cream 0.05%.

Key trial results include:

Zoryve cream 0.05% showed a well-tolerated, safe profile consistent with previous studies, with no new safety signals identified through 4 weeks of treatment. The most frequently reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting.

Zoryve cream 0.05% demonstrated rapid disease clearance through 4 weeks of treatment.

Among infants who completed 4 weeks of treatment in INTEGUMENT-INFANT (n=96), 34.4% achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success, defined as a score of 0 (Clear) or 1 (Almost Clear) with a ≥2-grade improvement from baseline.

58.3% of infants achieved at least a 75% reduction from baseline in Eczema Area and Severity Index (EASI-75) at Week 4, with 34% achieving EASI-75 at Week 2.

Among infants with at least mild scalp involvement at baseline, 67.5% (27/40) achieved vIGA-scalp success at Week 4.

Caregivers also reported rapid improvements in itch, with 46.6% of infants achieving at least a 25% improvement from baseline in pruritus within 10 minutes after application, as assessed by caregivers, based on the Dynamic Pruritus Scale (DPS-25) (n=88).

Zoryve cream 0.05% is a once-daily, steroid-free, non-greasy topical treatment that does not contain sensitizing excipients or irritants such as propylene glycol, polyethylene glycol, ethanol, or fragrances. Zoryve cream 0.05% is already approved for the treatment of mild to moderate atopic dermatitis in children aged 2-5 years.