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Submissions are supported by data from the Phase 3 Viti-Up clinical studies demonstrating upadacitinib achieved the co-primary endpoints of at least a 50% improvement in total body re-pigmentation (T-VASI 50) and at least a 75% improvement in facial re-pigmentation (F-VASI 75) from baseline at week 48.1
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If approved, upadacitinib will be the first systemic medication available for patients with vitiligo, addressing important treatment needs for those living with the chronic, unpredictable autoimmune disease.
NORTH CHICAGO, Ill., Feb. 3, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult and adolescent patients living with non-segmental vitiligo (NSV). The regulatory submissions to the FDA and EMA are supported by previously announced results from the Viti-Up studies evaluating the safety and efficacy of upadacitinib in patients with NSV.
Vitiligo is a chronic, autoimmune disease that imposes a significant psychosocial burden, profoundly affecting an individual's confidence, identity and daily life.2 NSV, the most common form of vitiligo (afflicting approximately 84% of patients), is marked by symmetrical and bilateral depigmented white patches and is prone to unpredictable progression even after long periods of stability.3-6 Vitiligo management is anchored in three primary treatment goals: disease stabilization, re-pigmentation, and maintaining re-pigmentation.7-9 There are currently no approved systemic medicines for achieving these treatment goals in vitiligo.
"Many patients experience ongoing frustration due to the unpredictability of non-segmental vitiligo spread and the lack of systemic treatment options that can stabilize disease progression and achieve skin re-pigmentation," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "The Viti-Up clinical studies explored these treatment gaps in vitiligo care and reinforced AbbVie's dedication to providing the first systemic treatment for patients, aiming to evolve the vitiligo treatment landscape."
About Viti-Up Clinical Studies1
Upadacitinib M19-044 was conducted under a single protocol encompassing two replicate Phase 3 studies (Study 1 and Study 2) with independent randomization, investigative sites, data collection, analysis and reporting for each study. The studies were designed to evaluate the efficacy, safety and tolerability of upadacitinib in adult and adolescent patients (ages 12 and older) living with non-segmental vitiligo (NSV) who were eligible for systemic therapy. In Period A of both studies, participants were randomized in a 2:1 ratio to receive either upadacitinib 15 mg once daily or placebo for 48 weeks. Participants who completed Period A were eligible to enter Period B, a 112-week open-label extension in which all patients received upadacitinib 15 mg once daily. In total, Study 1 and Study 2 Periods A and B span 160 weeks. The two studies randomized 614 participants with NSV across 90 sites worldwide. More information on these studies can be found at www.clinicaltrials.gov (NCT06118411).
The co-primary endpoints were based on the achievement of Total Vitiligo Area Scoring Index (T-VASI) 50, defined as at least 50% reduction in T-VASI from baseline, at week 48, and the achievement of Facial Vitiligo Area Scoring Index (F-VASI) 75, defined as at least 75% reduction in F-VASI from baseline, at week 48 with the treatment of upadacitinib 15 mg compared with placebo in adults and adolescents with NSV.
The secondary endpoints include the achievement of F-VASI 50, defined as at least a 50% reduction in F-VASI from baseline, at week 48, and the achievement of F-VASI 75, defined as at least a 75% reduction in facial vitiligo area from baseline, at week 24. These endpoints were designed to assess the degree and timing of re-pigmentation on the face, an area among the most visible and psychosocially impactful for people living with NSV.
About Vitiligo
Vitiligo is a chronic, autoimmune disease that imposes a significant psychosocial burden, profoundly affecting an individual's confidence, identity, and daily life. Non-segmental vitiligo (NSV), the most common form of vitiligo (afflicting approximately 84% of patients), is marked by symmetrical and bilateral depigmented white patches and is prone to unpredictable progression even after long periods of stability. While location varies, many patients report patches on critical areas such as the face, feet, hands and groin. Vitiligo management is anchored in three primary treatment goals: disease stabilization, re-pigmentation and maintaining re-pigmentation.
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.
Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. The use of upadacitinib in non-segmental vitiligo is not approved, and its safety and efficacy have not been evaluated by regulatory authorities.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio.
References
1.AbbVie. Data on file ABVRRTI82545
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8. Abdel-Malek ZA, Jordan C, HoT, Upadhyay PR, Fleischer A, Hamzavi l.. The enigma and challenges of vitiligo pathophysiology and treatment. Pigment Cell Melanoma Res. 2020;33(6):778-787. doi:10.1111/pcmr.12878
9.Birlea SA, Goldstein NB, Norris DA. Repigmentation through melanocyte regeneration in vitiligo. Dermatol Clin. 2017;35(2):205-218. doi:10.1016/j.det.2016.11.015
10.RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025