US biopharmaceutical company AbbVie (NYSE: ABBV) announced on Monday it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval of upadacitinib for adults and adolescents with non-segmental vitiligo.

A final decision from the European Commission is expected in the coming months, and approval would make upadacitinib the first systemic treatment for the condition.

The opinion is based on data from two Phase 3 Viti-Up studies, in which upadacitinib 15 mg met both co-primary endpoints at week 48, achieving at least a 50% improvement in total body re-pigmentation and at least a 75% improvement in facial re-pigmentation. Key secondary endpoints were also met, and the safety profile was consistent with that seen in approved indications.

Vitiligo is a chronic autoimmune disease marked by loss of pigment-producing cells, causing white patches that can appear anywhere on the body, with non-segmental vitiligo accounting for about 84% of cases.

The Viti-Up trials enrolled 614 patients aged 12 and older across 90 sites worldwide. Participants received either upadacitinib or placebo for 48 weeks before entering a 112-week open-label extension, bringing total study duration to 160 weeks.

Upadacitinib is already authorised in the European Union for several immune-mediated conditions, including atopic dermatitis, axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease and giant cell arteritis. Its use in non-segmental vitiligo remains under regulatory review in both the EU and the US.