Arcutis Biotherapeutics recently 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 as young as two years old.
Plaque psoriasis is the most common form of psoriasis in young children and frequently affects sensitive areas such as the face and intertriginous regions. This is particularly challenging for children under six, increasing the need for safe, effective, and well-tolerated management strategies.
According to Frank Watanabe, president and CEO at Arcutis, “This submission represents another important step forward in our goal to establish ZORYVE as foundational therapy for young children suffering with inflammatory skin diseases. Historically, many treatments for inflammatory skin diseases were not studied in children, creating challenges for the clinicians who treat these vulnerable patients. Arcutis is committed to helping to address this gap in treatment through conducting trials of ZORYVE in pediatric patients across a range of inflammatory skin diseases.”
The sNDA is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2–5 years with plaque psoriasis, as well as additional data from a long-term open-label study. Results indicate that ZORYVE demonstrated favorable long-term safety and tolerability, with persistent efficacy across the age ranges studied.
Currently approved for plaque psoriasis in adults and children aged six and older, ZORYVE is a once-daily, steroid-free, non-greasy cream. It contains no sensitizing excipients or irritants, such as propylene glycol, polyethylene glycol, ethanol, or fragrances. Additionally, ZORYVE is the only topical treatment specifically indicated for intertriginous psoriasis, with demonstrated efficacy, safety, and tolerability in both adults and children.
If approved, ZORYVE cream 0.3% would become the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as two years old.
“Today, there are very limited FDA-approved treatment options for plaque psoriasis for children under six, who often present with disease on sensitive skin such as the face and intertriginous areas. There is a significant unmet need for non-steroidal options that can effectively treat plaque psoriasis over the long-term. If approved, investigational ZORYVE cream could be an important first-line treatment option for children as young as age two,” said Adelaide A. Hebert, MD, professor and chief of pediatric dermatology at UTHealth Houston.
