Roflumilast cream 0.05% (Zoryve, Arcutis) is now commercially available in pharmacies for the treatment of mild-to-moderate atopic dermatitis (AD) in children ages 2 to 5 in the United States.
The product is being reviewed by commercial pharmacy benefit managers and other plans to enable similar coverage as the entire roflumilast portfolio.
On October 6, 2025, the U.S. Food and Drug Administration (FDA) approved roflumilast cream 0.05% 0.05% for the treatment of mild-to-moderate AD in children aged 2 to 5 years.
“With ZORYVE cream 0.05%, families have a once-daily, steroid-free, and well-tolerated treatment that targets the underlying inflammation of atopic dermatitis,” says Todd Edwards, Chief Commercial Officer at Arcutis. “ZORYVE provides a foundation for ongoing control, and can be used for any duration, anywhere on the body, with no restrictions on body surface area. We are excited to make this important treatment widely available to help improve outcomes for children and their families.”
“In my practice, I’ve seen firsthand how challenging atopic dermatitis can be for young children who deal with discomfort from the itch and rash, which can disrupt daily activities and sleep at night. In addition, parents and caregivers are looking for treatments that are not a steroid and are easy to apply,” adds Latanya Benjamin, MD, Associate Professor of Pediatric Dermatology at Florida Atlantic University’s Charles E. Schmidt College of Medicine in Boca Raton, FL. “I look forward to being able to offer ZORYVE cream 0.05% as a new advanced targeted topical for children with mild to moderate atopic dermatitis 2 to 5 years old and hopefully, bring some much-needed relief through its effective, yet gentle, skin-barrier-friendly formulation.”
Access Information
The ZORYVE Direct Program helps patients access their prescribed Arcutis medication. Specifically, this patient support program helps those who have been prescribed roflumilast cream to navigate the payer process, assists patients with adherence, and includes the ZORYVE Direct Savings Card Program, which can help reduce out-of-pocket costs for eligible commercially insured patients. Arcutis will also continue to offer the Arcutis Cares patient assistance program (PAP) that provides roflumilast cream at no cost for financially eligible patients who are uninsured or underinsured.
