FDA Accepts Arcutis' SNDA To Expand Zoryve Use To Children Aged 2-5

(RTTNews) - Commercial-stage biopharmaceutical company Arcutis Biotherapeutics, Inc. (ARQT), on Monday, said that the FDA has accepted a supplemental New Drug Application (sNDA) for Zoryve (roflumilast) cream, a once-daily, advanced targeted topical phosphodiesterase-4 (PDE4) inhibitor, to expand the indication for the topical treatment of plaque psoriasis to include children 2 to 5 years old.

The FDA has set a PDUFA target action date of June 29, 2026, for this application.

"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 Amy Paller, MS, MD, attending physician, dermatology, Walter J. Hamlin Professor and chair of dermatology, professor of pediatrics, Northwestern University Feinberg School of Medicine. "Effective and well-tolerated treatment options that are gentle enough for these areas are critical to support long-term disease control and improve quality of life for children and their families."

Zoryve cream 0.3% is currently approved for plaque psoriasis in adults and children down to age 6. This sNDA is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5 years with plaque psoriasis, as well as data from a long-term open-label study that included children in that age range.

Psoriasis is a common, chronic, inflammatory skin disease that affects nearly 9 million people in the United States. Symptoms include itch, scaling, redness, flaking, and pain. On darker skin tones, plaques may appear more grayish, purplish, or brown.