Health
AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Adults and Adolescents With Vitiligo
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 N
About this update from Abbvie Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"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","length":309,"tagName":"p"}]},{"val":[{"type":"text","content":"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. ","length":212,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":521,"olType":false},{"type":"text","content":"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.","length":563,"tagName":"p"},{"type":"text","content":"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.","length":650,"tagName":"p"},{"type":"text","content":""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 immun...