WILMINGTON, DE — Incyte (Nasdaq: INCY) secured European Commission approval for Opzelura cream to treat moderate atopic dermatitis in certain adults, giving the Wilmington-based drugmaker a second European indication for the therapy and expanding its reach into a chronic skin condition affecting millions of adults.
The approval covers adults for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or inappropriate. Opzelura, or ruxolitinib cream, becomes the first steroid-free topical JAK inhibitor approved in the European Union for atopic dermatitis, according to Incyte.
The European Commission’s decision follows a positive opinion issued in June by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Opzelura was previously approved in Europe to treat non-segmental vitiligo with facial involvement in adults and adolescents ages 12 and older.
The latest authorization is based on Incyte’s Phase 3b TRuE-AD4 study, supported by its Phase 3 TRuE-AD1 and TRuE-AD2 studies.
TRuE-AD4 evaluated adults with moderate atopic dermatitis who had an inadequate response, intolerance or contraindication to both topical corticosteroids and topical calcineurin inhibitors.
The study met both co-primary endpoints at eight weeks. A statistically significantly higher proportion of patients receiving Opzelura compared with vehicle cream achieved at least a 75% improvement on the Eczema Area and Severity Index, or EASI-75, and Investigator’s Global Assessment Treatment Success, defined as clear or almost-clear skin with at least a two-point improvement from baseline.
Among patients receiving Opzelura, 84.3% achieved EASI-75 at Week 24 with as-needed therapy, while 70.6% achieved the investigator-assessed treatment-success measure.
Mean affected body surface area declined from 15.1% at baseline to 2.5% at Week 8 and remained at 2.5% at Week 24. The proportion achieving at least a four-point improvement on an itch rating scale was 74.3% at Week 8 and 64.7% at Week 24.
Quality-of-life measures also improved. The mean Dermatology Life Quality Index score among Opzelura-treated patients fell from 19.3 at baseline to 4.3 at Week 8, compared with a decline from 19.1 to 10.7 among patients receiving vehicle cream.
Incyte reported no serious infections, major adverse cardiovascular events, malignancies or thromboses during the 24-week treatment period. The most common treatment-emergent adverse events were upper respiratory tract infections, reported in 10.6% of patients, and nasopharyngitis, reported in 6.3%.
The company also reported improvement in itching as early as Day 2.
“This approval represents an important new treatment option for patients who have not responded to topical corticosteroids or topical calcineurin inhibitors,” Andreas Wollenberg, professor of dermatology and allergy at University Hospital Augsburg in Germany, said.
Atopic dermatitis is a chronic, recurring inflammatory skin condition and the most common form of eczema. Incyte cited estimates putting prevalence among European adults at 4.4% to 7.1%, compared with as much as 4% of adults worldwide.
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