FDA Reviewing Roflumilast for Atopic Dermatitis in Toddlers

The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application for topical roflumilast, 0.05%, for the treatment of mild to moderate atopic dermatitis (AD) in children aged 2-5 years, according to a press release from manufacturer Arcutis Biotherapeutics.

Topical roflumilast (Zoryve), administered once daily, is a phosphodiesterase-4 inhibitor in a cream formulation currently approved in the 0.15% concentration for treating mild to moderate AD in patients aged 6 years or older. It is also approved, in the 0.3% concentration, for treating plaque psoriasis, including intertriginous areas, in children aged 6 years or older and in adults.

The FDA has set October 13, 2025, as the Prescription Drug User Fee Act target action date, according to the press release.

The supplemental application was based mainly on data from studies that included INTEGUMENT-PED, the pivotal phase 3 study that compared safety and efficacy of 0.05% once-daily roflumilast cream with a vehicle in 437 and 215 children aged 2-5 years (mean age, 3.3 years), respectively, with mild to moderate AD.

At 4 weeks, significantly more patients treated with roflumilast than those treated with vehicle met the primary endpoint of “clear” or “almost clear” skin based on the validated investigator global assessment–atopic dermatitis score, along with a minimum 2-grade improvement from baseline (25.4% vs 10.7%; P < .0001).

In addition, 39.4% of children in the roflumilast group achieved the key secondary endpoint of 75% improvement in eczema area and severity index, and significantly more children with extreme itching at baseline (defined as worst itch numeric scale score ≥ 4 at baseline) who were treated roflumilast showed a 4-point reduction in itch scores at 4 weeks compared with those treated with vehicle (35.3% vs 18.0%; nominal P = .0002).

The results were reported at the 2024 annual meeting of the American Academy of Dermatology.

Adverse events were low overall, and the safety profile in the study of younger children was similar to that seen in older children and adults, according to the company press release.