AbbVie submits FDA, EMA applications for upadacitinib (RINVOQ) in non-segmental vitiligo for 12 years and older

AbbVie announced that it has submitted regulatory applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval of upadacitinib (RINVOQ; 15 mg once daily) for the treatment of adults and adolescents aged 12 years and older with non-segmental vitiligo (NSV). If approved, upadacitinib would become the first systemic therapy available for patients with vitiligo, a chronic autoimmune disease associated with significant psychosocial burden.¹

The regulatory submissions are supported by results from the phase 3 Viti-Up clinical studies, which evaluated the safety and efficacy of upadacitinib in patients with NSV. According to AbbVie, the studies met their co-primary endpoints at week 48, demonstrating at least a 50% improvement in total body repigmentation, measured by the Total Vitiligo Area Scoring Index (T-VASI 50), and at least a 75% improvement in facial repigmentation, measured by the Facial Vitiligo Area Scoring Index (F-VASI 75), compared with baseline.

Vitiligo affects skin pigmentation through autoimmune destruction of melanocytes and is characterized by depigmented patches that may progress unpredictably. NSV is the most common subtype, accounting for approximately 84% of cases, and typically presents with symmetrical, bilateral lesions. Although disease stabilization and repigmentation are central goals of management, there are currently no approved systemic therapies for vitiligo, and treatment options are limited.

“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, MD, PhD, vice president and global head of immunology clinical development at 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.”

Phase 3 Viti-Up program design

The Viti-Up clinical program consisted of 2 replicate phase 3 studies conducted under a single protocol, with independent randomization, study sites, and analyses. The trials enrolled adults and adolescents aged 12 years and older with NSV who were considered eligible for systemic therapy. Across both studies, 614 participants were randomized at 90 sites worldwide.²

During Period A, participants were randomized in a 2:1 ratio to receive upadacitinib 15 mg once daily or placebo for 48 weeks. Those who completed Period A were eligible to enter Period B, a 112-week open-label extension in which all participants received upadacitinib 15 mg once daily, for a total study duration of 160 weeks.

In addition to the co-primary endpoints, secondary endpoints included achievement of F-VASI 50 at week 48 and F-VASI 75 at week 24. These measures were designed to assess both the magnitude and timing of facial repigmentation, which is often considered particularly meaningful for patients because of its visibility and psychosocial impact.

Clinical context and unmet needs

Vitiligo has long been recognized as a condition with effects extending beyond physical symptoms, often affecting quality of life, self-image, and social functioning. Lesions commonly involve highly visible or functionally sensitive areas, including the face, hands, feet, and groin. Current management strategies typically rely on topical therapies, phototherapy, or combinations of approaches, with variable and often incomplete responses.

AbbVie noted that the absence of approved systemic options represents a major unmet need in vitiligo care. The company’s submissions position upadacitinib as a potential therapy that could address disease stabilization and repigmentation in a broader population of patients, including adolescents.

About upadacitinib

Upadacitinib is an oral Janus kinase (JAK) inhibitor discovered and developed by AbbVie. Based on enzymatic and cellular assays, upadacitinib demonstrated greater inhibitory potency for JAK1 relative to JAK2, JAK3, and TYK2, although the clinical relevance of selective JAK inhibition is not fully defined. Upadacitinib is currently approved in the United States for multiple immune-mediated inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, and atopic dermatitis, among others.

The use of upadacitinib for non-segmental vitiligo is not currently approved, and its safety and efficacy for this indication have not yet been evaluated by regulatory authorities. AbbVie stated that prescribing information and regulatory decisions will be determined following review by the FDA and EMA.

If approved, upadacitinib would represent a first-in-class systemic option for vitiligo, potentially expanding the therapeutic landscape for a disease that has historically had limited treatment choices.

Approved pediatric indications for upadacitinib

• Adults and children 12 years of age and older with moderate to severe atopic dermatitis²
• Children 2 years of age and older with active polyarticular juvenile idiopathic arthritis
• Children 2 to less than 18 years of age with active psoriatic arthritis

References

1. AbbVie. AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Adults and Adolescents With Vitiligo. PR Newswire. February 3, 2026. Accessed February 3, 2026. https://www.prnewswire.com/news-releases/abbvie-submits-regulatory-applications-to-fda-and-ema-for-upadacitinib-rinvoq-in-adults-and-adolescents-with-vitiligo-302676972.html
2. AbbVie. AbbVie Announces Positive Topline Results from Phase 3 Pivotal Studies Evaluating Upadacitinib (RINVOQ®) in Adults and Adolescents with Vitiligo. AbbVie. October 29, 2025. Accessed February 3, 2026. https://news.abbvie.com/2025-10-29-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-Pivotal-Studies-Evaluating-Upadacitinib-RINVOQ-R-in-Adults-and-Adolescents-with-Vitiligo