North Chicago, Ill., July 29, 2026
AbbVie announced that the European Commission (EC) has approved RINVOQ® (upadacitinib) for the treatment of adults and adolescents aged 12 years and older with non-segmental vitiligo (NSV) who are eligible for systemic therapy. The approval marks a major milestone, making RINVOQ the first and only systemic medication authorized in the European Union for non-segmental vitiligo, the most common form of the disease. The decision is supported by positive Phase 3 Viti-Up clinical trial data, which demonstrated statistically significant improvements in both facial and total body repigmentation compared with placebo. The approval expands AbbVie’s growing immunology portfolio and offers a new treatment option for patients living with a chronic autoimmune skin disorder that often has a significant psychological and emotional impact.
Phase 3 Viti-Up Program Demonstrated Significant Repigmentation
The European Commission approval is based on findings from the Phase 3 Viti-Up clinical program, which included two randomized, double-blind, placebo-controlled studies evaluating RINVOQ 15 mg once daily in adults and adolescents with non-segmental vitiligo. The trials successfully achieved both co-primary endpoints, with patients experiencing statistically significant improvements in Total Vitiligo Area Scoring Index (T-VASI 50) and Facial Vitiligo Area Scoring Index (F-VASI 75) at Week 48 compared with placebo. In addition, key secondary endpoints were achieved, including stabilization of disease progression in patients with actively advancing vitiligo. The safety profile remained consistent with previously approved RINVOQ indications, with no new safety signals identified during the studies, further supporting its use in this patient population.
First Systemic Therapy Approved for Non-Segmental Vitiligo in Europe
The approval represents a significant advancement in the treatment landscape for non-segmental vitiligo, a chronic autoimmune disease that accounts for approximately 84% of all vitiligo cases. The condition results from immune-mediated destruction of melanocytes, leading to irregular depigmented skin patches and frequently causing depression, anxiety, and reduced quality of life. Unlike topical therapies, RINVOQ targets the underlying immune dysregulation responsible for disease progression, offering the potential to both stabilize disease activity and promote meaningful skin repigmentation. Investigators emphasized that early diagnosis and appropriate systemic treatment may improve long-term outcomes for patients experiencing active disease progression.
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Approval Strengthens AbbVie’s Expanding Immunology Portfolio
With this latest authorization, RINVOQ continues to broaden its presence across multiple immune-mediated diseases within the European Union. The medicine is already approved for conditions including atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, giant cell arteritis, axial spondyloarthritis, and severe alopecia areata. Meanwhile, upadacitinib remains under review by the U.S. Food and Drug Administration (FDA) for non-segmental vitiligo, highlighting its potential to expand treatment options globally. AbbVie continues advancing late-stage clinical development across additional autoimmune disorders, reinforcing its long-term strategy to deliver innovative therapies addressing significant unmet medical needs in immunology.
Source: AbbVie press release
