FDA Sets Review Date for ZORYVE Cream Expansion in Young Children with Plaque Psoriasis

Arcutis Biotherapeutics announced that the U.S. Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.3%, a topical phosphodiesterase-4 (PDE4) inhibitor, for the treatment of plaque psoriasis in children aged 2 to 5 years. The agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026.

If approved, ZORYVE cream 0.3% would become the first topical PDE4 inhibitor indicated for plaque psoriasis in patients as young as two years old. The product is currently approved for use in adults and children six years and older.

The sNDA submission is supported by data from a four-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5, as well as a long-term open-label study that included participants in that age group. According to Arcutis, results from these studies demonstrated consistent safety and tolerability profiles, along with sustained efficacy.

“Plaque psoriasis in young children can be particularly challenging to manage, as it often affects sensitive areas such as the face and intertriginous skin,” said Dr. Amy Paller, dermatologist and chair of dermatology at Northwestern University Feinberg School of Medicine. She noted the need for treatment options that are appropriate for these areas and age groups.

Frank Watanabe, president and CEO of Arcutis, stated that the submission reflects the company’s aim to provide treatment options for pediatric patients with immune-mediated skin conditions. He added that, if approved, ZORYVE cream 0.3% would represent a non-steroidal treatment option for younger children with plaque psoriasis.

Psoriasis is a chronic inflammatory skin condition that affects nearly 9 million people in the United States. It is characterized by symptoms such as itching, scaling, and inflammation. In children, the condition often affects areas like the face and skin folds, which may present treatment challenges.

ZORYVE cream is a once-daily topical formulation of roflumilast, a PDE4 inhibitor that targets inflammatory pathways in the skin. The product is currently approved for multiple inflammatory skin diseases and has received industry recognition, including awards and endorsements from dermatologic organizations.