EC Approves Opzelura for Moderate Atopic Dermatitis in Adults – Incyte

Incyte announced that the EC has approved Opzelura (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate.

“The European Commission’s approval of Opzelura is an important milestone for adults in Europe living with moderate atopic dermatitis who need more treatment options. As the first steroid-free topical JAK inhibitor approved in the EU for atopic dermatitis, Opzelura offers an effective new treatment choice and reflects our commitment to advancing innovation for people with inflammatory and autoimmune diseases.” – Bill Meury, Chief Executive Officer, Incyte.

The EC decision follows the June 2026 positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This marks the second indication in Europe for Opzelura, which was previously approved by the EC as a treatment for non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

This approval is based on data from the pivotal Phase 3b TRuE-AD4 study (NCT06238817) evaluating the safety and efficacy of Opzelura in adults with moderate AD, and is supported by the Phase 3 TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651) studies.

In TRuE-AD4, Opzelura significantly improved the clinical signs and symptoms of moderate AD, including itch as early as Day 2.1 Opzelura was well tolerated in adults who had an inadequate response, intolerance or contraindication to both TCSs and TCIs.1 In the TRuE-AD4 study the co-primary endpoints were met at Week 8, with a statistically significantly higher proportion of patients on Opzelura versus vehicle cream achieving a ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75), and, separately, Investigator’s Global Assessment Treatment Success (IGA-TS, defined as an IGA score of 0 [clear] or 1 [almost clear] with at least a two-point improvement from baseline).

Efficacy was maintained following the initial treatment period with 84.3% of patients achieving EASI75 and 70.6% achieving IGA-TS with as needed therapy at Week 24.3 Mean affected body surface area (BSA) decreased markedly from 15.1% at baseline to 2.5% at Week 8 and remained low at Week 24 (2.5%), while itch relief (NRS4; ≥4-point improvement in Itch Numeric Rating Scale) remained high (74.3% at Week 8 and 64.7% at Week 24) with Opzelura treatment.

Additionally, patients treated with Opzelura also showed improvements in quality of life, with mean Dermatology Life Quality Index (DLQI) scores improving from 19.3 at baseline to 4.3 at Week 8, compared with 19.1 to 10.7 with vehicle cream (control).

Opzelura was well tolerated, with no serious infections, major adverse cardiovascular events, malignancies or thromboses reported during the 24-week treatment period.2 The most common treatment-emergent adverse events were upper respiratory tract infection (10.6%) and nasopharyngitis (6.3%).

“Despite advances in the treatment of moderate atopic dermatitis, many patients continue to face residual symptoms that can affect their everyday quality of life, underscoring the need for additional treatment options. This approval represents an important new treatment option for patients who have not responded to topical corticosteroids or topical calcineurin inhibitors, offering the potential to improve disease management and reduce the burden of their condition on everyday life.” – Prof. Andreas Wollenberg, Professor of Dermatology and Allergy, University Hospital Augsburg, Germany.

The most common type of eczema, AD, is a chronic recurring, inflammatory and highly pruritic skin condition that affects up to 4% of adults worldwide, with an estimated prevalence of 4.4-7.1% of adults in Europe.6,7,8,9 Signs and symptoms of AD include, but are not limited to, irritated and itchy skin that can cause red lesions that may ooze and crust.