Biopharmaceutical company Incyte (Nasdaq:INCY) announced on Wednesday that the European Commission has approved Opzelura (ruxolitinib) cream for adults with moderate atopic dermatitis who have an inadequate response to or cannot use topical corticosteroids and topical calcineurin inhibitors.

This approval makes Opzelura the first steroid-free topical JAK inhibitor approved in the European Union for atopic dermatitis and represents the product's second indication in Europe.

The decision is supported by Phase 3b TRuE-AD4 data, which showed Opzelura met both co-primary endpoints at Week 8, maintained disease control with as-needed treatment through Week 24, and was well tolerated.

In the study, Opzelura demonstrated improvements in clinical signs and symptoms, including itch relief, with 84.3% of patients achieving EASI-75 and 70.6% achieving Investigator's Global Assessment Treatment Success at Week 24 with as-needed therapy.

The treatment also improved quality-of-life measures, while the company reported no serious infections, major adverse cardiovascular events, malignancies, or thromboses during the 24-week treatment period.