WILMINGTON, Del., July 29, 2026
Incyte announced that the European Commission (EC) has approved Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients whose disease is inadequately controlled with, intolerant to, or unsuitable for topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs). The approval makes Opzelura the first steroid-free topical Janus kinase (JAK) inhibitor approved in the European Union for adults with moderate AD, providing a new treatment option for patients requiring an alternative to conventional topical therapies. The regulatory decision follows the positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued in June 2026 and marks the second approved indication for Opzelura in Europe, following its earlier approval for non-segmental vitiligo with facial involvement.
Phase 3b TRuE-AD4 Trial Demonstrated Significant Clinical Benefits
The EC approval was primarily supported by data from the pivotal Phase 3b TRuE-AD4 clinical study, alongside findings from the Phase 3 TRuE-AD1 and TRuE-AD2 trials. In the study, Opzelura successfully met both co-primary endpoints at Week 8, with significantly more patients achieving EASI-75 and Investigator’s Global Assessment Treatment Success (IGA-TS) compared with vehicle cream. The therapy also demonstrated rapid itch relief as early as Day 2, while delivering sustained improvements through 24 weeks using an as-needed treatment approach. By Week 24, 84.3% of patients maintained EASI-75, while 70.6% achieved IGA Treatment Success, highlighting the cream’s ability to provide durable disease control. Patients also experienced marked reductions in affected body surface area, continued improvement in itch severity, and meaningful gains in quality of life, reflected by significant reductions in Dermatology Life Quality Index (DLQI) scores.
Favorable Safety Profile Supports Long-Term Treatment
Throughout the 24-week study period, Opzelura maintained a favorable safety profile with no serious infections, major adverse cardiovascular events, malignancies, or thromboses reported. The most frequently observed treatment-emergent adverse events included upper respiratory tract infection and nasopharyngitis, with overall tolerability remaining consistent with previous clinical studies. As a selective JAK1/JAK2 inhibitor, Opzelura offers a steroid-free topical treatment option that addresses inflammation while avoiding prolonged corticosteroid exposure, an important consideration for patients requiring long-term disease management. The cream is specifically intended for adults whose moderate atopic dermatitis remains uncontrolled despite existing topical therapies or for whom those treatments are unsuitable.
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Approval Expands Incyte’s Dermatology Portfolio in Europe
The latest European Commission approval further strengthens Incyte’s growing presence in inflammatory and autoimmune skin diseases while expanding treatment options for the millions of adults living with moderate atopic dermatitis across Europe. Atopic dermatitis remains a chronic, relapsing inflammatory skin disorder characterized by persistent itching, skin inflammation, and significant impairment of daily quality of life. Company leadership emphasized that the approval reflects its continued commitment to delivering innovative therapies for patients with unmet medical needs. With Opzelura now approved in Europe for both non-segmental vitiligo and moderate atopic dermatitis, Incyte continues to broaden its dermatology portfolio while reinforcing the potential of targeted JAK inhibition as an effective approach for managing chronic inflammatory skin diseases.
Source:Incyte press release
