AbbVie Advances Rinvoq as Potential Vitiligo Treatment Through FDA and EMA Submissions

AbbVie, a leading global pharmaceutical company, has taken a significant step in expanding Rinvoq’s therapeutic applications by submitting regulatory applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval as a treatment for adult and adolescent patients with non-segmental vitiligo (NSV). This represents a new indication for the drug in addressing a challenging pigmentation disorder.

Promising Clinical Trial Results for Vitiligo Management

The regulatory submissions are grounded in robust Phase 3 clinical data from the Viti-Up studies, which demonstrated that upadacitinib—the active component of Rinvoq—successfully met both co-primary efficacy endpoints. Specifically, the trial showed that at least 50% of patients achieved meaningful total body repigmentation, while at least 75% experienced substantial facial repigmentation improvements measured at the 48-week mark. These results indicate the drug’s potential effectiveness in restoring skin pigmentation for vitiligo patients.

Broader Therapeutic Profile and Mechanism

Beyond vitiligo treatment, Rinvoq has already established clinical utility as a prescription medication addressing various immune-mediated inflammatory conditions. The drug is currently approved for managing rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, among other inflammatory disorders. This existing safety and efficacy profile strengthens the case for its application in vitiligo, where immune system dysfunction plays a central role in pigment loss.

Regulatory Path Forward

If approved, Rinvoq would offer patients with vitiligo a new pharmacological option backed by rigorous clinical evidence. The FDA and EMA submissions represent the next critical phase in determining whether the drug will become available for this patient population in major markets.