AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Non-segmental Vitiligo

AbbVie said the European Medicines Agency’s CHMP issued a positive opinion recommending approval of upadacitinib (RINVOQ) for adults and adolescents with non-segmental vitiligo. The announcement came June 29, 2026, with the final European Commission decision expected in the coming months. If approved, upadacitinib is expected to be the first systemic therapy for this indication, addressing treatment needs in non-segmental vitiligo, which the company describes as the most common form affecting about 84% of patients. The CHMP opinion is based on Phase 3 Viti-Up trials, in which upadacitinib 15 mg once daily met co-primary endpoints at week 48: at least 50% improvement in total body repigmentation (T-VASI 50) and at least 75% improvement in facial repigmentation (F-VASI 75). AbbVie also said the safety profile matched previously approved uses, with no new safety signals. AbbVie noted the EU currently does not approve upadacitinib for NSV.