Incyte Announces Positive CHMP Opinion for Opzelura® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis

About this update from Incyte Corporation

Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of 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. “AD is a chronic skin condition that can have a significant impact on daily life. The positive CHMP opinion for Opzelura marks meaningful progress toward bringing the first non-steroidal topical JAK treatment option to adults in Europe with moderate AD for whom standard topical therapies have failed,” said Lee Heeson, Executive Vice President and Head of Incyte International. “If approved by the European Commission, Opzelura could help address an important gap for patients who have limited treatment options when TCSs and TCIs are inadequate or inappropriate.” The positive CHMP opinion is based on results from the pivotal Phase 3 TRuE-AD4 study (NCT06238817), supported by the Phase 3 TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651) studies, evaluating the safety and efficacy of ruxolitinib cream in adults with AD.4,6,7 In TRuE-AD4, ruxolitinib cream significantly improved the clinical signs and symptoms of moderate AD, including itch, as early as Day 2 and was well tolerated in adults who had an inadequate response, intolerance or contraindication to both TCSs and TCIs.3 The TRuE‑AD4 study met its co‑primary endpoints at Week 8, with a statistically significantly higher proportion of patients on ruxolitinib cream versus vehicle cream achieving a ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI75), 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).3 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 24.5 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 ruxolitinib cr...

View stock analysis, news, and events for Incyte Corporation