Incyte (Nasdaq: INCY) announced that 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 are inadequate or inappropriate.

The company claims the product is the first steroid-free topical JAK inhibitor approved in the European Union for atopic dermatitis. The EC decision follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use in June 2026. This marks the second approved indication for Opzelura in Europe, following an earlier approval for non-segmental vitiligo with facial involvement in adults and adolescents aged 12 and older.

The approval is based on data from the Phase 3b TRuE-AD4 study, which enrolled 241 adults with moderate atopic dermatitis who had an inadequate response, intolerance, or contraindication to both topical corticosteroids and topical calcineurin inhibitors. The study met both co-primary endpoints at Week 8, with a statistically higher proportion of patients treated with Opzelura achieving a 75% or greater improvement in the Eczema Area and Severity Index score and Investigator's Global Assessment Treatment Success compared with vehicle cream.

At Week 24, 84.3% of patients achieved EASI75 and 70.6% achieved IGA Treatment Success with as-needed therapy. Mean affected body surface area decreased from 15.1% at baseline to 2.5% at Week 8 and remained at 2.5% at Week 24. Itch relief was reported in 74.3% of patients at Week 8 and 64.7% at Week 24.

Mean Dermatology Life Quality Index scores improved from 19.3 at baseline to 4.3 at Week 8 among Opzelura-treated patients, compared with a change from 19.1 to 10.7 in the vehicle cream group.

No serious infections, major adverse cardiovascular events, malignancies, or thromboses were reported during the 24-week treatment period. The most common treatment-emergent adverse events were upper respiratory tract infection at 10.6% and nasopharyngitis at 6.3%.

Incyte holds worldwide rights for the development and commercialization of Opzelura.