Incyte Corporation has announced an extension in the regulatory review process by the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura®). This topical Janus kinase (JAK) inhibitor is intended for the treatment of children aged 2-11 with mild to moderate atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) action date has now been extended by three months to September 19, 2025. This extension allows the FDA additional time to review newly submitted chemistry, manufacturing, and controls data related to the 0.75% strength cream. The sNDA is supported by data from the Phase 3 TRuE-AD3 study, which demonstrated significant efficacy and a consistent safety profile for ruxolitinib cream in the pediatric population.
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