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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

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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