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) for the treatment of children aged 2 to 11 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, Incyte reports.
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.
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 ruxolitinib cream achieving Investigator’s Global Assessment-treatment success (IGA-TS) than patients treated with vehicle control. 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.
The overall safety profile of Opzelura in the TRuE-AD3 trial was consistent with previous data, and no new safety signals were observed. No serious infections, major adverse cardiovascular events (MACE), malignancies or thromboses were reported during the 8-week vehicle-controlled period. The most common treatment-related adverse event among patients treated with Opzelura was application site pain (2.7% vs 0% in vehicle arm). These events were mild and did not lead to treatment interruption.
