AbbVie 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.

Offering a Systematic Medication for Treating Vitiligo

Vitiligo is 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 and is prone to unpredictable progression even after long periods of stability. Vitiligo management is anchored in three primary treatment goals: disease stabilization, re-pigmentation, and maintaining re-pigmentation. There are currently no approved systemic medicines for achieving these treatment goals in vitiligo.

“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 immunology clinical development, AbbVie. “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.”