AbbVie Pursues FDA and EMA Approval for Rinvoq in Non-Segmental Vitiligo Treatment

AbbVie has filed regulatory submissions with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking to expand Rinvoq’s therapeutic applications into the vitiligo treatment arena. This strategic move marks a significant step in addressing non-segmental vitiligo (NSV), a chronic autoimmune skin condition affecting millions of patients worldwide who struggle with unpredictable pigmentation loss.

Compelling Phase 3 Evidence in Vitiligo Clinical Development

The regulatory filings are supported by robust data from the Phase 3 Viti-Up clinical trials. The studies demonstrated that upadacitinib, Rinvoq’s active pharmaceutical ingredient, achieved both co-primary efficacy endpoints. Specifically, the drug achieved at least 50% improvement in total body repigmentation and at least 75% improvement in facial repigmentation when measured at the 48-week mark compared to baseline. These results represent a meaningful advance for vitiligo patients, particularly given the disease’s psychological and social impact on sufferers.

The facial repigmentation improvement rate of 75% holds particular clinical significance, as patients often prioritize visible facial areas for aesthetic and psychosocial reasons. This level of efficacy addresses a long-standing unmet medical need in dermatology and immunology.

Rinvoq’s Growing Portfolio Beyond Vitiligo

While Rinvoq pursues this new indication, the drug already carries FDA approval for treating multiple immune-mediated inflammatory diseases. Current approved uses include rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and several other inflammatory conditions. This expanding treatment profile underscores AbbVie’s commitment to leveraging upadacitinib’s immunomodulatory properties across diverse disease states.

The regulatory approval landscape for vitiligo represents a relatively untapped opportunity within the broader immunology and dermatology markets. Successful approval would position Rinvoq as a novel therapeutic option for a patient population with limited treatment alternatives, potentially reshaping the vitiligo management paradigm.