Press release
Incyte Announces Positive CHMP Opinion for Ruxolitinib Cream (Opzelura™) for the Treatment of Non-segmental Vitiligo in Adults and Adolescents
At approval, ruxolitinib cream will be the first treatment for repigmentation in non-segmental vitiligo available in the European Union (EU) In Europe, there
About this update from Incyte Corporation
[{"type":"text","content":"\n\nAt approval, ruxolitinib cream will be the first treatment for repigmentation in non-segmental vitiligo available in the European Union (EU)\n\n\nIn Europe, there are approximately 1.5 million patients diagnosed with vitiligo, a progressive and complex disease with a high unmet need\n\n\nThe positive CHMP opinion is based on Phase 3 data showing treatment with ruxolitinib cream resulted in improvements in facial and total body repigmentation1\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of ruxolitinib cream (Opzelura™) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.\n\n“The positive CHMP opinion brings us one step closer to bringing ruxolitinib cream, the first ever treatment for repigmentation in non-segmental vitiligo, to patients and healthcare professionals in the European Union (EU),” said Steven Stein, M.D., Chief Medical Officer, Chief Medical Officer, Incyte. “With no centrally approved treatment option currently available in the EU, this positive opinion marks a significant milestone for the vitiligo community.”\n\nThe CHMP opinion recommending the approval of ruxolitinib cream was based on data from two pivotal Phase 3 clinical trials (TRuE-V1 and TRuE-V2) evaluating the safety and efficacy of ruxolitinib cream versus vehicle (non-medicated cream) in more than 600 people with non-segmental vitiligo, age 12 and older1. Results from the TRuE-V program, recently published in The New England Journal of Medicine, showed that treatment with ruxolitinib cream resulted in significant improvements in facial and total body repigmentation versus vehicle as shown by the number of patients reaching the facial and total body Vitiligo Area Scoring Index (F-VASI-T-VASI) endpoints at Week 24 compared to vehicle, with a higher proportion of patients responding at Week 521. The most common adverse reactions (incidence ≥ 1%) were application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia2.\n\nThe CHMP’s opinion is now being reviewed by the European Commission, which has the authority to grant centralized ...