FDA Approves Topical Cream for Pediatric Atopic Dermatitis

The FDA approved a supplemental New Drug Application for roflumilast (Zoryve, Arcutis Biotherapeutics) cream 0.05% to treat mild to moderate atopic dermatitis in pediatric patients aged 2 to 5 years.

The approval of the cream calls for it to be applied once daily anywhere on the body with atopic dermatitis, potentially replacing topical steroids, which were previously viewed as the standard of care for this condition. 

“It is essential to have safe and effective treatments for children, who are often diagnosed with atopic dermatitis at a young age and can live with the condition across their lifetime,” Lawrence F. Eichenfield, MD, the chief of pediatric and adolescent dermatology at Rady Children’s Hospital - San Diego and INTEGUMENT study investigator, said in a statement. “Young children often experience widespread disease, affecting large portions of their skin. Although topical steroids have been the standard treatment for years, they are not appropriate for long-term use.”

Roflumilast cream was created to address an unmet need in treating atopic dermatitis, targeting the underlying inflammation without compromising the skin barrier, which is especially crucial for younger patients. 

This is the sixth FDA approval for the product in the last three years after a number of clinical trials involving patients of all ages.

“In clinical trials, Zoryve cream 0.05% rapidly improved the severity and extent of eczema (atopic dermatitis) signs and symptoms,

with approximately 40% of children achieving a 75% improvement from baseline as measured by EASI [the Eczema Area and Severity Index], and more than one-third (35%) achieving a clinically meaningful improvement in itch intensity, both in only four weeks,” Eichenfield said. “With this approval, healthcare providers and families have an effective new treatment option for young children with atopic dermatitis.”

— Kenny Walter