Arcutis Biotherapeutics, Inc. has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication of roflumilast cream 0.3% (Zoryve) for the treatment of plaque psoriasis in children down to the age 2.
If approved, roflumilast cream 0.3% would be the first and only topical PDE4 inhibitor treatment indicated for plaque psoriasis in children down to age 2.
The sNDA is supported by data from a four-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5 with plaque psoriasis, as well as data from a long-term open-label study. Results from the long-term study demonstrate consistent favorable long-term safety and tolerability as well as persistence of efficacy across the age ranges studied.
A Significant Unmet Need
“Today, there are very limited FDA-approved treatment options for plaque psoriasis for children under 6, 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,” says Adelaide Hebert, MD, Professor and Chief of Pediatric Dermatology at UTHealth in Houston, TX, in a news release. “If approved, investigational ZORYVE cream could be an important first-line treatment option for children as young as age 2.”
“This submission represents another important step forward in our goal to establish ZORYVE as foundational therapy for young children suffering with inflammatory skin diseases,” adds Frank Watanabe, President and CEO at Arcutis. “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.”
Roflumilast cream 0.3% is currently approved for plaque psoriasis, including intertriginous areas, in adults and children down to age 6.
