AbbVie’s Upadacitinib Clears Regulatory Hurdle for Vitiligo Treatment

The recommendation follows results from the Phase 3 Viti-Up clinical program, which enrolled 614 participants across 90 global sites. In these trials, patients receiving a 15 mg daily dose of upadacitinib demonstrated significant improvements in skin repigmentation. By the 48-week mark, treatment groups met co-primary endpoints, achieving at least 50% improvement in total body repigmentation and 75% improvement in facial repigmentation compared to placebo.

Non-segmental vitiligo affects approximately 84% of vitiligo patients, causing symmetrical white patches that often appear on the face, hands, and feet. Beyond the physical depigmentation, the condition frequently carries a heavy psychosocial burden. Roopal Thakkar, executive vice president of research and development at AbbVie, noted that the positive opinion marks a critical step toward providing a systemic option for a disease that has historically lacked targeted pharmacological therapies. The company reported that the drug's safety profile remained consistent with its existing indications, with no new safety signals identified during the study.