AbbVie's Ubadacitinib Receives FDA and EMA Approval for Vitiligo Treatment
On February 3, 2026, AbbVie (NYSE: ABBV) announced that it has submitted a supplemental application for the approval of ubadacitinib (15 mg, once daily) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This application targets the treatment of adults and adolescents suffering from Non-segmental Vitiligo (NSV). The submission is based on previously reported results from the phase 3 Viti-Up trial, which evaluated the safety and efficacy of ubadacitinib in patients with vitiligo.
Vitiligo is a chronic autoimmune condition with significant psychosocial burdens, deeply affecting patients' confidence, identity, and daily lives. NSV accounts for around 84% of vitiligo cases, characterized by symmetrical depigmented patches on both sides of the body. Patients often experience unpredictable disease progression, even after prolonged periods of stability. Currently, there are no approved systemic therapies available to achieve the three primary treatment goals: stabilization of the disease, repigmentation, and maintenance of repigmentation.
Kori Wallace, M.D., Ph.D., Vice President and Global Head of Immunology Clinical Development at AbbVie, stated: "Many patients are frustrated due to the unpredictable progression of NSV symptoms and the limited options for systemic treatments that could suppress this progression and promote skin repigmentation. The Viti-Up trial was designed to address these challenges and demonstrates AbbVie's commitment to advancing treatment options for vitiligo by providing the first systemic therapy for this condition."
The phase 3 trial M19-044 consists of two identical studies (Study 1 and Study 2) conducted under a single investigational plan. These trials independently assessed the efficacy, safety, and tolerability of ubadacitinib in adults and adolescents (aged 12 and older) with NSV who are candidates for systemic therapy. Patients were randomized to receive either ubadacitinib (15 mg once daily) or a placebo for 48 weeks.
Patients who completed the 48-week A phase could transition to the 112-week B phase, where all participants received ubadacitinib. Altogether, the two studies spanned a total of 160 weeks with 614 NSV patients randomized across 90 sites worldwide. Detailed information about these studies can be found at www.clinicaltrials.gov (NCT06118411).
The main co-primary endpoints evaluated were the achievement of a Total Vitiligo Area Scoring Index (T-VASI) 50 at week 48 (defined as a reduction of more than 50% from baseline) and a Facial Vitiligo Area Scoring Index (F-VASI) 75 at week 48 (defined as a reduction of more than 75% from baseline). Secondary endpoints included the achievement of F-VASI 50 at week 48 and F-VASI 75 at week 24. These metrics focused on the facial region, as it's one of the most visible and impactful areas for individuals living with NSV, assessing the extent and timing of repigmentation.
Vitiligo, a chronic autoimmune disorder, substantially impacts patients' psychosocial well-being. It manifests through depigmented patches, predominantly in visible areas such as the face and extremities. Management focuses on stabilizing the condition, achieving repigmentation, and maintaining this repigmentation. The unpredictable nature of NSV often complicates this management.
Ubadacitinib, developed by AbbVie's scientists, is a Janus kinase (JAK) inhibitor under investigation for several immune-mediated inflammatory diseases. In assays that utilize enzymes and cells, ubadacitinib exhibited strong inhibitory activity primarily against JAK-1 compared to JAK-2, JAK-3, and TYK-2. While the exact correlation between the inhibition of specific JAK enzymes and treatment effects or safety profiles remains unclear, ongoing studies are crucial for understanding these relationships.
Ubadacitinib is currently undergoing phase 3 trials for alopecia areata, hidradenitis suppurativa, giant cell arteritis, systemic lupus erythematosus, and vitiligo. Its use for NSV remains unapproved, pending regulatory reviews to ascertain its safety and efficacy. The advancements in treatment epitomize the ongoing battle against this chronic condition and highlight the potential for improved patient outcomes with innovative therapies.
Vitiligo is a chronic autoimmune condition with significant psychosocial burdens, deeply affecting patients' confidence, identity, and daily lives. NSV accounts for around 84% of vitiligo cases, characterized by symmetrical depigmented patches on both sides of the body. Patients often experience unpredictable disease progression, even after prolonged periods of stability. Currently, there are no approved systemic therapies available to achieve the three primary treatment goals: stabilization of the disease, repigmentation, and maintenance of repigmentation.
Kori Wallace, M.D., Ph.D., Vice President and Global Head of Immunology Clinical Development at AbbVie, stated: "Many patients are frustrated due to the unpredictable progression of NSV symptoms and the limited options for systemic treatments that could suppress this progression and promote skin repigmentation. The Viti-Up trial was designed to address these challenges and demonstrates AbbVie's commitment to advancing treatment options for vitiligo by providing the first systemic therapy for this condition."
Overview of the Viti-Up Trial
The phase 3 trial M19-044 consists of two identical studies (Study 1 and Study 2) conducted under a single investigational plan. These trials independently assessed the efficacy, safety, and tolerability of ubadacitinib in adults and adolescents (aged 12 and older) with NSV who are candidates for systemic therapy. Patients were randomized to receive either ubadacitinib (15 mg once daily) or a placebo for 48 weeks.
Patients who completed the 48-week A phase could transition to the 112-week B phase, where all participants received ubadacitinib. Altogether, the two studies spanned a total of 160 weeks with 614 NSV patients randomized across 90 sites worldwide. Detailed information about these studies can be found at www.clinicaltrials.gov (NCT06118411).
Key Evaluation Metrics
The main co-primary endpoints evaluated were the achievement of a Total Vitiligo Area Scoring Index (T-VASI) 50 at week 48 (defined as a reduction of more than 50% from baseline) and a Facial Vitiligo Area Scoring Index (F-VASI) 75 at week 48 (defined as a reduction of more than 75% from baseline). Secondary endpoints included the achievement of F-VASI 50 at week 48 and F-VASI 75 at week 24. These metrics focused on the facial region, as it's one of the most visible and impactful areas for individuals living with NSV, assessing the extent and timing of repigmentation.
Understanding Vitiligo
Vitiligo, a chronic autoimmune disorder, substantially impacts patients' psychosocial well-being. It manifests through depigmented patches, predominantly in visible areas such as the face and extremities. Management focuses on stabilizing the condition, achieving repigmentation, and maintaining this repigmentation. The unpredictable nature of NSV often complicates this management.
About Ubadacitinib
Ubadacitinib, developed by AbbVie's scientists, is a Janus kinase (JAK) inhibitor under investigation for several immune-mediated inflammatory diseases. In assays that utilize enzymes and cells, ubadacitinib exhibited strong inhibitory activity primarily against JAK-1 compared to JAK-2, JAK-3, and TYK-2. While the exact correlation between the inhibition of specific JAK enzymes and treatment effects or safety profiles remains unclear, ongoing studies are crucial for understanding these relationships.
Ubadacitinib is currently undergoing phase 3 trials for alopecia areata, hidradenitis suppurativa, giant cell arteritis, systemic lupus erythematosus, and vitiligo. Its use for NSV remains unapproved, pending regulatory reviews to ascertain its safety and efficacy. The advancements in treatment epitomize the ongoing battle against this chronic condition and highlight the potential for improved patient outcomes with innovative therapies.
Topics Health）
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