Arcutis Seeks FDA Greenlight to Expand ZORYVE for Children Under 6
Key Takeaways:
Arcutis announced that it has submitted an sNDA to the FDA to expand ZORYVE 0.3% for plaque psoriasis in children aged 2 to 5.
If approved, ZORYVE would be the first topical PDE4 inhibitor indicated for this pediatric group.
Safety and efficacy data were derived from the MUSE study and a long-term open-label extension in young children.
Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication of ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children aged 2 to 5, according to a press release from the manufacturer.
Arcutis said the expansion is supported by data from the Maximal Usage Systemic Exposure (MUSE) study and a long-term open-label study of children in the target age group. ZORYVE was well tolerated and showed sustained efficacy. ZORYVE is currently approved for treating plaque psoriasis in patients 6 years and older, including in intertriginous areas. If approved for the expansion, it will become the first and only PDE4 inhibitor indicated for treating psoriasis in this very young patient population.
“There is a significant unmet need for non-steroidal options that can effectively treat plaque psoriasis over the long-term,” said Adelaide Hebert, MD, professor and chief of pediatric dermatology at UTHealth Houston, in the press release. “If approved, investigational ZORYVE cream could be an important first-line treatment option for children as young as age 2”.
ZORYVE cream has previously received the National Psoriasis Foundation’s Seal of Recognition and is approved for use in adults and children for multiple indications, including atopic dermatitis and seborrheic dermatitis via various formulations. According to the press release, this recent research shows ZORYVE demonstrating "consistent favorable long-term safety and tolerability as well as persistence of efficacy across the age ranges studied.”
Source: Arcutis press release. September 3, 2025.