The European Commission has approved Opzelura (ruxolitinib) cream for the treatment of moderate atopic dermatitis in adult patients for whom topical corticosteroids and topical calcineurin inhibitors have proven inadequate or inappropriate — making it the first steroid-free topical JAK inhibitor approved for the condition in the European Union.
The decision follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use in June 2026. It marks the second approved indication for Opzelura in Europe; the cream was previously authorized for non-segmental vitiligo with facial involvement in adults and adolescents 12 and older.
The approval is grounded in data from the Phase 3b TRuE-AD4 trial, which enrolled 241 adults with moderate atopic dermatitis who had failed prior topical therapies. The study met both co-primary endpoints at Week 8, with a statistically significantly higher proportion of patients on Opzelura achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) and Investigator's Global Assessment Treatment Success compared to vehicle cream. Itch relief began as early as Day 2.
Results held up over time: 84.3% of patients maintained EASI-75 response at Week 24 with as-needed dosing, and mean affected body surface area fell from 15.1% at baseline to 2.5% by Week 8, remaining low through the study's end. Quality of life scores improved substantially, with Dermatology Life Quality Index scores dropping from 19.3 to 4.3 at Week 8 among Opzelura-treated patients, compared to 19.1 to 10.7 in the control group.
The drug was well tolerated, with no serious infections, cardiovascular events, malignancies, or thromboses reported over 24 weeks. The most common side effects were upper respiratory tract infection and nasopharyngitis.
Atopic dermatitis affects an estimated 4.4–7.1% of adults in Europe.
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