Business Wire·Jul 29, 2026, 6:00 AM ET

Opzelura® (ruxolitinib) Cream Becomes First Steroid-Free Topical JAK Inhibitor Approved in the European Union for Adults with Moderate Atopic Dermatitis

INCY

The European Commission has approved Opzelura (ruxolitinib) cream for treating moderate atopic dermatitis in adults who have inadequate response, intolerance, or contraindications to topical corticosteroids or calcineurin inhibitors.
Approval was granted based on Phase 3b TRuE-AD4 data showing the drug met both co-primary endpoints at Week 8 & maintained disease control through Week 24 with as-needed treatment.
Opzelura is the first steroid-free topical JAK inhibitor approved in the EU for atopic dermatitis, marking its second indication in Europe following prior approval for non-segmental vitiligo.
In the TRuE-AD4 study, patients achieved statistically significant improvements in EASI-75 (≥75% improvement in Eczema Area and Severity Index) & IGA-TS (clear or almost clear skin with two-point improvement) at Week 8.
Efficacy was sustained at Week 24 with 84.3% of patients achieving EASI75 & 70.6% achieving IGA-TS using as-needed therapy.
Mean affected body surface area decreased from 15.1% at baseline to 2.5% at Week 8 & remained at 2.5% at Week 24.
Itch relief was reported by 74.3% of patients at Week 8 & 64.7% at Week 24 based on a ≥4-point improvement in the Itch Numeric Rating Scale.
Quality of life improved significantly, with mean Dermatology Life Quality Index scores dropping from 19.3 at baseline to 4.3 at Week 8.
The treatment was well tolerated over 24 weeks with no serious infections, major adverse cardiovascular events, malignancies, or thromboses reported.
The most common adverse events were upper respiratory tract infection (10.6%) & nasopharyngitis (6.3%).
The European Medicines Agency's CHMP issued a positive opinion for this indication in June 2026 prior to the Commission's decision.
Incyte holds worldwide rights for the development & commercialization of Opzelura.