The FDA has approved the supplemental new drug application for topical roflumilast cream 0.05% for treating mild-to-moderate atopic dermatitis in children aged 2-5 years, the manufacturer announced in a press release on October 6. 

Roflumilast cream, marketed as Zoryve by Arcutis Biotherapeutics, is a phosphodiesterase 4 inhibitor administered once daily. It was previously approved in a 0.15% concentration for treatment of mild-to-moderate atopic dermatitis in patients aged 6 years and older and in a 0.3% concentration for the treatment of plaque psoriasis, including intertriginous areas, in adults and children aged 6 years and older.

In addition to an extension study and a phase 1 pharmacokinetic study, the additional approval was based on data from the phase 3 INTEGUMENT-PED study, in which nearly 40% of children treated with roflumilast 0.05% achieved a 75% improvement from baseline on the Eczema Area and Severity Index 75% score at 4 weeks vs 20% of those using the vehicle, according to the press release. Also at week 4, 25.4% of those on active treatment had a score of 0 (clear) or 1 (almost clear) on the validated Investigator Global Assessment for Atopic Dermatitis scale and a 2-grade improvement from baseline compared with 10.7% of those using the vehicle (P < .0001).

Itching also was reduced with treatment, according to the company. Results of the study were previously presented at the annual meeting of the American Academy of Dermatology in 2024, and were reported by Medscape.

In pivotal studies, treatment was well-tolerated and the most common adverse effects reported were upper respiratory tract infection, diarrhea, vomiting, rhinitis, conjunctivitis, and headache, the company said in the release. 

This approval follows the recent FDA approval of ruxolitinib cream 1.5% (Opzelura), a topical JAK inhibitor, as a treatment for mild-to-moderate AD in children ages 2-11 years, as previously reported by Medscape.

Topical roflumilast 0.05% is expected to be available at the end of October 2025, according to the company. Full prescribing information is available here.