Press release
Incyte Announces European Commission Approval of Opzelura® (ruxolitinib) Cream for the Treatment of Non-Segmental Vitiligo with Facial Involvement in Adults and Adolescents
Opzelura® (ruxolitinib) Cream is the first approved treatment in the European Union (EU) to address repigmentation in non-segmental vitiligo Phase 3 data
About this update from Incyte Corporation
[{"type":"text","content":"\n\nOpzelura® (ruxolitinib) Cream is the first approved treatment in the European Union (EU) to address repigmentation in non-segmental vitiligo\n\n\n\n\nPhase 3 data supporting the approval show treatment with Opzelura resulted in improved facial and total body repigmentation, sustained and continued improvements with longer duration of treatment\n\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced that the European Commission (EC) has granted a marketing authorization for Opzelura® (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Opzelura is the first and only approved treatment in the European Union (EU) to offer support for repigmentation in eligible patients with non-segmental vitiligo, a chronic autoimmune disease characterized by depigmentation of skin and reduced quality of life.\n\n\nThe EC decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) earlier this year and is applicable to all 27 European Union Member States, Iceland, Norway and Liechtenstein.\n\n\n“The approval of Opzelura by the European Commission represents a significant advancement for people living with non-segmental vitiligo with facial involvement who, until now, had no approved medical treatment to address repigmentation,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “This approval wouldn’t have been possible without the support of the vitiligo patient and medical community, and the efforts of our research and development teams. We will now work across individual countries in Europe to bring this much awaited therapy to eligible patients seeking to treat their vitiligo.”\n\n\nThe EC decision is based on data from two pivotal Phase 3 clinical trials (TRuE-V1 [NCT04052425] and TRuE-V2 [NCT04057573]), evaluating the efficacy and safety of Opzelura versus vehicle (non-medicated cream) in more than 600 people with non-segmental vitiligo, age 12 and older. Results from the TRuE-V program showed that treatment with Opzelura 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 ...