Arcutis Strengthens Commitment To Pediatric Dermatology With FDA Submission Of Supplemental NDA For ZORYVE® (roflumilast) Cream 0.3% To Treat Plaque Psoriasis In Children Ages 2 to 5

Arcutis Biotherapeutics, Inc., a commercial-stage biopharmaceutical company dedicated to advancing innovations in immuno-dermatology, has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ZORYVE® (roflumilast) cream 0.3%. The application seeks to expand the current indication to include the treatment of plaque psoriasis in children as young as two years old. If approved, ZORYVE cream would become the first and only topical PDE4 inhibitor available for children aged two and older with plaque psoriasis.

Plaque psoriasis is the most common form of psoriasis in young children and presents with similar characteristics as in adults. However, in children under the age of six, the condition often affects sensitive areas such as the face and intertriginous regions, creating additional challenges for safe and effective long-term management.

ZORYVE cream 0.3% is a once-daily, steroid-free topical treatment that is non-greasy and free of irritants or sensitizing excipients, including propylene glycol, polyethylene glycol, ethanol, and fragrances. It is the only topical therapy specifically approved for intertriginous psoriasis and has demonstrated favorable efficacy, safety, and tolerability in both adults and pediatric patients.

Adelaide Hebert, MD, professor and chief of pediatric dermatology at UTHealth Houston, stated, “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. If approved, investigational ZORYVE cream could be an important first-line treatment option for children as young as age 2.”

Frank Watanabe, president and CEO at Arcutis, mentioned, “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.”

Currently, ZORYVE cream 0.3% is approved for the treatment of plaque psoriasis in adults and children aged six years and older. The new sNDA is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study conducted in children between the ages of 2 and 5 with plaque psoriasis, along with findings from a long-term open-label study. 

Results from these studies showed consistent safety and tolerability as well as sustained efficacy across younger age groups. This submission represents a potential step forward in providing a safe, effective, and child-friendly treatment option for young children living with plaque psoriasis, where therapeutic choices remain limited.