AbbVie Pursues FDA and EMA Approval for Rinvoq to Treat Vitiligo

AbbVie has filed regulatory applications with both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of its drug Rinvoq for treating adult and adolescent patients with non-segmental vitiligo (NSV), a chronic skin condition affecting pigmentation. The filings are backed by compelling results from the Phase 3 Viti-Up clinical trial program, which evaluated upadacitinib—the active component of Rinvoq—in vitiligo patients.

Strong Clinical Data Supports Regulatory Advancement

The Phase 3 Viti-Up studies revealed impressive efficacy outcomes on dual primary endpoints. Upadacitinib met the target of achieving at least 50% total body repigmentation in treatment-eligible participants, while also demonstrating at least 75% improvement in facial repigmentation from baseline measurements at the 48-week mark. These results underscore the drug’s potential to address a significant unmet need in vitiligo management, where treatment options have historically been limited.

Expanding Platform for Immune-Mediated Diseases

Beyond vitiligo, Rinvoq has already earned FDA approval for multiple immune-mediated inflammatory conditions, including rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. This regulatory expansion demonstrates the broad applicability of upadacitinib’s mechanism of action, positioning the drug as a cornerstone therapy within AbbVie’s immunology portfolio. Success in the vitiligo indication would further strengthen Rinvoq’s market presence and therapeutic versatility.

The regulatory pathway for vitiligo treatment represents an important milestone for AbbVie and offers new hope for patients managing this challenging dermatological condition, pending FDA and EMA decisions.