Christopher Bunick, MD, PhD, Reviews Expanded Roflumilast Cream Approval for Pediatric Plaque Psoriasis

On June 29, 2026, the FDA approved roflumilast cream 0.3% (Zoryve; Arcutis Biotherapeutics) for the topical treatment of plaque psoriasis, including intertriginous areas, in pediatric patients as young as 2 years of age. The approval expands the existing indication, which previously covered patients down to age 6, making roflumilast 0.3% cream the first and only once-daily topical therapy for children with plaque psoriasis as young as 2.¹ Christopher Bunick, MD, PhD, editor in chief of Dermatology Times and associate professor of dermatology at Yale School of Medicine, discussed the clinical significance of the approval for providers treating young patients.

Mechanism and Clinical Profile

Roflumilast cream's efficacy stems from its targeted mechanism: it mimics cyclic AMP and inhibits the phosphodiesterase type 4 (PDE4) enzyme. Bunick noted the approval is built on the agent's well-known safety and tolerability, established across clinical studies in adults and adolescents. This pharmacologic profile, he said, supports the agent's use in children requiring long-term non-steroidal therapy.

"This is built off of roflumilast's well-known safety and tolerability, as well as its efficacy, which stems from that unique molecular ability for it to mimic cyclic AMP and inhibit the PDE4 enzyme," Bunick said.

Intertriginous Involvement and the Case for Non-Steroidal Therapy

Bunick highlighted the approval's particular clinical relevance for children with intertriginous or skinfold involvement. These are areas where providers may need to rely on non-steroidal therapy for prolonged periods, and options for this age group have been limited. Roflumilast cream, as a once-daily agent approved for use on any body site without duration restrictions, directly addresses this need.

"This is a really wonderful opportunity for providers treating children with plaque psoriasis, particularly those with intertriginous or skinfold involvement, where you may need a non-steroidal therapy for prolonged periods of time," Bunick said.

Steroid Stewardship in Pediatric Plaque Psoriasis

Bunick also noted the approval's implications for steroid stewardship more broadly. Access to a once-daily non-steroidal therapy for pediatric plaque psoriasis, he said, reduces reliance on long-term topical corticosteroids for providers who need an alternative.

He characterized the approval as a win for the clinicians and patients most in need of a reliable non-steroidal management option.

"This is a win for those patients and providers that need that once-daily non-steroidal advanced therapy, like roflumilast 0.3% cream," Bunick concluded.

Reference

1. FDA approves Arcutis' Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children as young as age 2. News release. Arcutis Biotherapeutics. June 29, 2026. Accessed June 30, 2026. https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-03-treatment-0