US pharmaceutical company AbbVie (NYSE:ABBV) announced on Tuesday that it has submitted applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for a new indication of upadacitinib (RINVOQ; 15 mg, once daily) for the treatment of adult and adolescent patients living with non-segmental vitiligo (NSV).

The regulatory submissions were based on results from the Viti-Up studies evaluating the safety and efficacy of upadacitinib in patients with NSV, a chronic, autoimmune disease that imposes a significant psychosocial burden, profoundly affecting an individual's confidence, identity, and daily life.

NSV, the most common form of vitiligo (afflicting approximately 84% of patients), is marked by symmetrical and bilateral depigmented white patches on the skin and is prone to unpredictable progression even after long periods of stability.

In the Phase 3 Viti-Up clinical studies, upadacitinib achieved the co-primary endpoints of at least a 50% improvement in total body re-pigmentation and at least a 75% improvement in facial re-pigmentation from baseline at week 48.

If approved, upadacitinib will be the first systemic medication available for patients with vitiligo.