Zoryve cream sNDA accepted for atopic dermatitis in infants down to 3 months
- Sponsor
- Arcutis Biotherapeutics $ARQT
- Drug
- Zoryve · roflumilast
- Indication
- Atopic dermatitis, mild-to-moderate, topical (cream 0.05%), in infants aged 3-24 months
FDA accepted Arcutis's supplemental NDA for ZORYVE (roflumilast) cream 0.05% to expand the topical mild-to-moderate atopic dermatitis indication to infants aged 3 to 24 months. PDUFA target action date is February 23, 2027.
What this means
Zoryve is a once-daily cream containing roflumilast, a steroid-free anti-inflammatory that blocks PDE-4, an enzyme involved in eczema. The FDA agreed to review Arcutis's application to expand Zoryve's use to mild-to-moderate atopic dermatitis in infants aged 3 to 24 months, with a decision expected by February 2027. If approved, Zoryve would join Pfizer's Eucrisa (crisaborole, cleared for the same age group in 2020) as a steroid-free topical prescription option available to infants with eczema.
From the source
WESTLAKE VILLAGE, Calif., July 08, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months. The FDA has set a PDUFA target action date of February 23, 2027.
Highlights: - FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027 - Application supported by positive results from Phase 2 open-label INTEGUMENT-INFANT study and Phase 1 open-label pharmacokinetic (PK) study - 1 million children under the age of 2 are treated topically for atopic dermatitis in the United States, representing 10% of all adults and children treated topically for atopic dermatitis
Reproduced from GlobeNewswire — Arcutis Biotherapeutics · view original · public domain or open-licensed government work
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