WASHINGTON (dpa-AFX) - AbbVie (ABBV) on Tuesday said it has submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of Rinvoq for the treatment of adult and adolescent patients with non-segmental vitiligo (NSV).
The submissions are based on data from the Phase 3 Viti-Up studies, which showed that upadacitinib met the co-primary endpoints of at least 50% improvement in total body repigmentation and at least 75% improvement in facial repigmentation from baseline at week 48.
Rinvoq is a prescription medicine approved for a range of immune-mediated inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and ulcerative colitis among others.
AbbVie shares closed at $225.64 on Monday, up 1.18%.
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