FDA approves roflumilast cream for patients aged ≥2 years with plaque PsO

On June 29, 2026, the U.S. Food and Drug Administration (FDA) approved a label expansion for roflumilast 0.3% cream for the treatment of children aged ≥2 years with plaque psoriasis (PsO), including intertriginous areas.¹ The cream was previously approved for pediatric patients aged 6–11 years with plaque psoriasis in October 2023.

This label expansion was supported by results from a phase II, 4-week Maximal Usage Systemic Exposure (MUSE) study (NCT04746911), which evaluated the pharmacokinetics, safety, tolerability, and exploratory efficacy of roflumilast 0.3% cream in children aged 2–5 years with plaque PsO involving ≥2% body surface area.¹ Supportive long-term safety data were obtained from the phase III, open-label extension DERMIS-OLE study (NCT04286607), in which roflumilast demonstrated safety and efficacy profiles similar to those observed in adolescents and adults in the phase III DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389) trials.¹