AbbVie Files FDA, EMA Applications for Upadacitinib in Non-Segmental Vitiligo

Key Takeaways

• AbbVie has submitted FDA and EMA applications for upadacitinib in adults and adolescents with non-segmental vitiligo.

• The phase 3 Viti-Up studies met co-primary endpoints for total body and facial re-pigmentation at week 48.

• Approval would mark the first systemic medication available for vitiligo management.

AbbVie has submitted regulatory applications to the US Food and Drug Administration and European Medicines Agency seeking approval of upadacitinib (RINVOQ) for the treatment of adults and adolescents with non-segmental vitiligo (NSV), according to a press release from the manufacturer.

The submissions were supported by data from the phase 3 Viti-Up clinical trial program (NCT06118411) evaluating the safety and efficacy of the oral JAK inhibitor in patients with NSV. Upadacitinib met both co-primary endpoints at week 48, achieving at least a 50% improvement in total body re-pigmentation, as measured by the Total Vitiligo Area Scoring Index (T-VASI 50), and at least a 75% improvement in facial re-pigmentation (F-VASI 75) from baseline.

Despite the commonality and chronic autoimmune nature and well-documented psychosocial burden of non-segmental vitiligo, treatment options remain limited, particularly for patients with extensive or progressive disease. Current strategies involve disease stabilization, re-pigmentation, and maintenance of pigment.

"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, global head of immunology clinical development, AbbVie, said in the news release. "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."