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Arcutis Says FDA Accepts sNDA For ZORYVE Cream 0.3% To Expand Indication For Topical Treatment Of Plaque Psoriasis To Include Children 2 To 5 Years Old; PDUFA Target Action Date Set For June 29, 2026

Benzinga·11/17/2025 13:11:30
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  • Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026
  • If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2

WESTLAKE VILLAGE, Calif., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA acceptance of a supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.3%, 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.