Arcutis Biotherapeutics Wins FDA Approval for Pediatric Eczema Cream
Zoryve (roflumilast) cream 0.05% gains supplemental approval to treat atopic dermatitis in children as young as two years old.
Arcutis Biotherapeutics (NASDAQ: ARQT) announced it has received a significant regulatory win after the for Zoryve (roflumilast) cream 0.05%.
The approval expands the topical treatment's indication to include mild to moderate atopic dermatitis, commonly known as eczema, in pediatric patients aged 2 to 5 years. This decision opens up a crucial new market for the once-daily, steroid-free cream, addressing what the company calls a significant unmet need for safe and effective long-term treatments for younger children.
The regulatory green light was granted ahead of the scheduled October 13, 2025, target action date and marks the sixth FDA approval for Arcutis's roflumilast portfolio in just over three years. The company confirmed that the commercial product is expected to be available by the end of October 2025.
Approval was based on positive results from a robust clinical trial program, including the . Data from the trials demonstrated that Zoryve provided rapid and substantial improvements in the signs and symptoms of eczema. Notably, approximately 40% of children treated with the cream achieved a 75% improvement from their baseline condition as measured by the Eczema Area and Severity Index (EASI), with over a third experiencing clinically meaningful itch reduction within four weeks.
For parents and pediatricians, the approval offers a new, non-steroidal option that can be applied anywhere on the body without the duration limitations often associated with topical steroids. This is particularly important for young children, who frequently experience widespread eczema and for whom long-term steroid use carries potential risks. The into this younger demographic positions Arcutis to capture a greater share of the lucrative dermatology market.