USFDAJul 8, 2026, 08:01 AM
Arcutis FDA Accepts ZORYVE sNDA for Infants; PDUFA Feb 23, 2027
AI Summary
Arcutis Biotherapeutics announced that the FDA has accepted its supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.05%. This sNDA aims 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. The application is supported by positive results from the Phase 2 open-label INTEGUMENT-INFANT study and a Phase 1 pharmacokinetic study, demonstrating a well-tolerated profile and rapid disease clearance.
Key Highlights
- FDA accepted sNDA for ZORYVE cream 0.05% for infants aged 3 to 24 months.
- PDUFA target action date set for February 23, 2027.
- Application supported by positive Phase 2 INTEGUMENT-INFANT study results.
- Also supported by positive Phase 1 pharmacokinetic (PK) study results.
- INTEGUMENT-INFANT study showed 34.4% achieved vIGA-AD success at Week 4.
- 58.3% of infants achieved at least 75% reduction in EASI-75 at Week 4.
- ZORYVE cream 0.05% is already approved for children aged 2-5 years.
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