FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Infants Down to 3 Months
The FDA accepted Arcutis' supplemental New Drug Application for ZORYVE cream 0.05% to treat mild to moderate atopic dermatitis in infants aged 3 to 24 months, setting a PDUFA target action date of February 23, 2027. The application is supported by positive Phase 2 data from the INTEGUMENT-INFANT study, where 34.4% of infants achieved vIGA-AD success and 58.3% achieved EASI-75 at week 4, with a safety profile consistent with older cohorts.
Key figures
- Drug Name
- ZORYVE® (roflumilast) cream 0.05%
- Phase Of Trial
- Phase 2
- Pdufa date
- February 23, 2027
- Addressable population infants
- 1 million children
AI analysis
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