Arcutis Submits sNDA To Expand ZORYVE Cream Use For Plaque Psoriasis In Children As Young As 2

Author: Benzinga Newsdesk | September 03, 2025 11:47am

• If approved, ZORYVE cream would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2, offering patients and caregivers an important alternative to topical steroids and vitamin-D analogs
• ZORYVE cream is uniquely formulated to be effective, safe, and well tolerated for all areas of the body, including sensitive areas such as intertriginous skin, where plaque psoriasis often presents in children

WESTLAKE VILLAGE, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of 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 down to the age of 2. If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor treatment indicated for plaque psoriasis in children down to age 2.

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