AT A GLANCE

A new FDA submission seeks to expand the use of roflumilast cream for plaque psoriasis to children as young as 2. Clinical data from a maximal use study and a long-term extension trial highlight favorable safety, tolerability, and durable efficacy in this population. 

Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking to expand the indication of roflumilast 0.3% cream (ZORYVE®) for the treatment of plaque psoriasis in children ages 2–5 years. If approved, the drug would become the first topical phosphodiesterase-4 (PDE4) inhibitor authorized for this population, addressing a key therapeutic gap for pediatric patients.

Plaque psoriasis is the most common form of psoriasis in children, and those under 6 years frequently present with lesions on sensitive skin, such as intertriginous and facial areas, where conventional therapies like corticosteroids and vitamin D analogs pose challenges for long-term use. The sNDA is supported by findings from a 4-week Maximal Usage Systemic Exposure (MUSE) trial and a long-term open-label extension, both demonstrating favorable safety, tolerability, and sustained efficacy in this younger cohort. By extending pediatric access, roflumilast cream has the potential to provide clinicians with a non-steroidal, once-daily therapy designed for use across all body regions, including delicate sites of disease involvement.

DRUG AT A GLANCE

ZORYVE® (roflumilast) cream is a topical phosphodiesterase-4 (PDE4) inhibitor that is U.S. Food and Drug Administration approved for the treatment of plaque psoriasis in adults and children ages 6 and older. A supplemental New Drug Application (sNDA) is currently under FDA review to expand the indication to children as young as 2 years, which would make it the first and only topical PDE4 inhibitor approved for pediatric plaque psoriasis.