EU approves Incyte's Opzelura cream for moderate atopic dermatitis

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Go back to EU approves Incyte's Opzelura cream for moderate atopic dermatitis

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

July 29, 2026 6:00 AM EDT

The European Commission approval is based on Phase 3b TRuEAD4 data which demonstrated that Opzelura® (ruxolitinib) cream met both coprimary endpoints at Week 8, maintained disease control with as-needed treatment through Week 24, and was well tolerated 1,2,3

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq: INCY) today announced that the European Commission (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... More