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EU Approves AbbVie's RINVOQ as First Systemic Treatment for Vitiligo

The European Commission has authorized RINVOQ (upadacitinib) for the treatment of non-segmental vitiligo in adults and adolescents, marking the first time a systemic medication has been approved for the condition in the European Union.

EU Approves AbbVie's RINVOQ as First Systemic Treatment for Vitiligo
Photo: Bio & News

The approval, announced by AbbVie, applies to patients 12 years and older who are candidates for systemic therapy. Vitiligo, a chronic autoimmune disease, causes the selective destruction of skin melanocytes and results in irregular white patches. Beyond the physical manifestations, the condition often carries a heavy psychological burden, including high rates of depression and anxiety.

Clinical support for the decision came from the Phase 3 Viti-Up program. Studies demonstrated that a 15 mg daily dose of the JAK inhibitor achieved statistically significant improvements in both facial and total body repigmentation compared to a placebo at 48 weeks. Researchers also noted that the treatment showed potential in stabilizing disease progression for patients with active lesions. According to Dr. Diamant Thaçi, a trial investigator at the University of Lübeck, the therapy targets underlying immune dysregulation, offering a new path for managing the unpredictable nature of the disease.

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