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

INCY
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of Opzelura (ruxolitinib) cream for adults with moderate atopic dermatitis (AD) who have inadequate responses to topical corticosteroids or topical calcineurin inhibitors.
  • If approved by the European Commission, Opzelura will become the first steroid-free, topical JAK treatment option in the EU for this patient population.
  • The recommendation is based on Phase 3 TRuE-AD4 data, which showed the drug met both co-primary endpoints at Week 8 with statistically significant improvements in EASI75 and Investigator's Global Assessment Treatment Success compared to vehicle cream.
  • Clinical efficacy was maintained through Week 24 using as-needed treatment, with 84.3% of patients achieving EASI75 and 70.6% achieving IGA-TS.
  • Patients experienced rapid symptom relief, including itch reduction, as early as Day 2, with mean affected body surface area decreasing from 15.1% at baseline to 2.5% at Week 8.
  • Quality of life improvements were observed, with mean Dermatology Life Quality Index scores dropping from 19.3 at baseline to 4.3 at Week 8.
  • The treatment was well tolerated over 24 weeks, with no reported serious infections, major adverse cardiovascular events, malignancies, or thromboses.
  • The most common treatment-emergent adverse events were upper respiratory tract infection (10.6%) and nasopharyngitis (6.3%).
  • The CHMP opinion is now under review by the European Commission, which holds final authority for granting EU marketing authorization.
  • This would be the second indication for Opzelura in the EU, following its previous approval for non-segmental vitiligo with facial involvement.
  • Incyte holds worldwide rights for the development and commercialization of Opzelura.