The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for roflumilast cream 0.3% (Zoryve, Arcutis) to treat plaque psoriasis in children aged 2 to 5.
The Prescription Drug User Fee Act (PDUFA) target action date is June 29, 2026.
Roflumilast cream 0.3% is currently approved for plaque psoriasis in adults and children down to age 6. If approved, it would be the first and only topical phosphodiesterase 4 (PDE4) inhibitor indicated for plaque psoriasis in children as young as 2.
“Plaque psoriasis in young children can be particularly challenging to manage, as it often affects sensitive areas such as the face and intertriginous skin,” says Amy Paller, MS, MD, the Walter J. Hamlin Professor and Chair of Dermatology and a Professor of Pediatrics at Northwestern University Feinberg School of Medicine in Chicago, IL. “Effective and well-tolerated treatment options that are gentle enough for these areas are critical to support long-term disease control and improve quality of life for children and their families.”
This sNDA is supported by data from a four-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5 years with plaque psoriasis, as well as data from a long-term open-label study that included children in that age range. Results from this long-term study demonstrate consistent favorable long-term safety and tolerability as well as persistence of efficacy across all age ranges studied.
