Incyte announces that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura, Incyte), a topical Janus kinase (JAK) inhibitor, for the treatment of children 2-11 years old with mild-to-moderate atopic dermatitis (AD).
The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to September 19, 2025.
The FDA extended the PDUFA action date to allow time to review additional chemistry, manufacturing, and controls (CMC) data on the 0.75% strength submitted by Incyte in response to a recent FDA information request.
“Atopic dermatitis (AD) is a chronic immune-mediated skin condition that can be difficult to manage, particularly for the millions of children in the U.S. affected by AD,” said Steven Stein, M.D., Chief Medical Officer, Incyte, in a news release. “We are confident in the potential of ruxolitinib cream to become an important non-steroidal, topical treatment option for pediatric patients with atopic dermatitis and we will continue to work closely with the FDA to ensure the Agency has all of the information needed to complete its review.”
The sNDA submission for ruxolitinib cream in pediatric AD was based on data from the Phase 3 TRuE-AD3 study, which evaluated the safety and efficacy of ruxolitinib cream in children (age ≥2 to <12 years) with AD. The TRuE-AD3 study met its primary endpoint with significantly more patients treated with Opzelura achieving Investigator’s Global Assessment-treatment success (IGA-TS), a measure of treatment efficacy, than patients treated with vehicle control (non-medicated cream). In addition, a secondary endpoint of patients demonstrating at least a 75% improvement in the Eczema Area and Severity Index (EASI75) at Week 8 was also achieved.
