Incyte receives positive CHMP opinion for Opzelura in moderate atopic dermatitis

• Incyte (NASDAQ:INCY) announced that the CHMP recommended approval of Opzelura (ruxolitinib) cream for moderate atopic dermatitis in adults who have an inadequate response, intolerance, or contraindication to topical corticosteroids and topical calcineurin inhibitors.
• The positive opinion is based on the Phase 3 TRuE-AD4 study, which showed significant improvements in skin clearance, itch, and quality of life.
• If approved by the European Commission, Opzelura would become the first topical JAK inhibitor for moderate atopic dermatitis in the EU.

Incyte (NASDAQ:INCY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of 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 recommendation is based on results from the pivotal Phase 3 TRuE-AD4 study, supported by data from the TRuE-AD1 and TRuE-AD2 trials.

In TRuE-AD4, ruxolitinib cream demonstrated statistically significant and clinically meaningful improvements in EASI75 and Investigator’s Global Assessment Treatment Success at Week 8 versus vehicle cream, with rapid itch relief observed as early as Day 2.

Efficacy was maintained through Week 24 with as-needed use, while patients also experienced meaningful improvements in quality of life as measured by the Dermatology Life Quality Index.

Opzelura was generally well tolerated, with no new safety signals observed in the studies.

If approved by the European Commission, this would mark the second indication for Opzelura in the EU, following its existing approval for non-segmental vitiligo with facial involvement.