AbbVie Files FDA and EMA Applications for Oral RINVOQ in Non-Segmental Vitiligo

AbbVie has submitted FDA and EMA applications for upadacitinib in non-segmental vitiligo for adults and adolescents, according to a recent press release. If approved, the filing would position upadacitinib (RINVOQ) as a potential first systemic medication option for vitiligo management.

Upadacitinib (RINVOQ) is an oral Janus kinase (JAK) inhibitor; in non-segmental vitiligo, it is being evaluated as a systemic approach rather than a purely topical or device-based strategy. For clinicians, the most relevant near-term signal is how the phase 3 readouts translate into labeled endpoints, patient selection, and monitoring language if approval is granted.

The submissions cite the Viti-Up phase 3 program (NCT06118411), which evaluated the safety and efficacy of oral upadacitinib in patients with non-segmental vitiligo (NSV). As presented in the filing narrative, the week-48 co-primary endpoints serve as the central efficacy benchmarks supporting the applications.

Both co-primary endpoints were met at week 48, using threshold-based repigmentation targets that separate whole-body from facial response. T‑VASI 50 is defined as a ≥50% improvement in total-body repigmentation measured by the Total Vitiligo Area Scoring Index, and F‑VASI 75 is defined as a ≥75% improvement in facial repigmentation from baseline.

Non-segmental vitiligo remains a chronic autoimmune disease with substantial psychosocial burden and a treatment landscape that is still limited—especially for patients with extensive or progressive disease. In practice, frustration often centers on unpredictable spread and the lack of systemic options that can both stabilize progression and support meaningful repigmentation. Management goals are typically practical and longitudinal: stabilize disease activity, achieve repigmentation where possible, and maintain pigment over time.