The US Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ once-daily Zoryve (roflumilast) cream to treat mild-to-moderate atopic dermatitis (AD) in adult and paediatric patients aged six years and older.

Affecting approximately 16.5 million adults and 9.6 million children in the US, AD is a common inflammatory condition that causes the skin to become itchy, dry and cracked.

Zoryve is a steroid-free topical PDE4 inhibitor that is already approved by the FDA to treat seborrhoeic dermatitis and plaque psoriasis.

Among the data supporting the regulator’s latest decision were results from the late-stage INTEGUMENT-1 and INTEGUMENT-2 trials, in which more than 1,300 AD patients received either Zoryve cream 0.15% or vehicle once daily for four weeks.

In both studies, approximately 40% of adults and children treated with Zoryve cream achieved a vIGA-AD score of zero (clear) or one (almost clear) at week four, with significant improvements seen as early as week one.

Rapid and significant improvements in itch, which Arcutis notes as being “the most burdensome symptom” of AD, were also observed in Zoryve-treated patients within 24 hours of the first application, and more than 40% of patients receiving Zoryve achieved a 75% reduction in Eczema Area and Severity Index at week four compared to vehicle.

Results from another phase 3 study, as well as a phase 2 dose-ranging study and two phase 1 pharmacokinetic studies, also supported the FDA’s approval.

INTEGUMENT study investigator Lawrence Eichenfield, UC San Diego School of Medicine, said: “The chronic nature of AD coupled with the disease instability often leaves patients and caregivers feeling that they are constantly chasing their AD flares… Having a new and effective steroid-free option without some of the risks associated with topical and systemic steroids is a welcome advancement for dermatologists, patients and caregivers.”