AbbVie Seeks FDA, EMA Approval for Rinvoq in Non-Segmental Vitiligo: ABBV

[Para 1: The Lead] AbbVie Inc. (NYSE: ABBV) has submitted applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of its drug Rinvoq (upadacitinib) for the treatment of non-segmental vitiligo, a condition characterized by skin depigmentation. The submission marks a significant step in the company's dermatology pipeline, aiming to provide a new treatment option for patients suffering from this chronic condition. [Para 2-3: Supporting details & Context] The applications are based on data from the Phase 3 clinical trial program, which demonstrated that Rinvoq significantly improved skin pigmentation in patients with non-segmental vitiligo compared to placebo. The primary endpoint of the study was achieved with a 20% or greater improvement in the extent of depigmented skin at week 24. Financially, the approval could bolster AbbVie's dermatology portfolio, which includes Humira (adalimumab) and Viekira Pak (ombitasvir/paritaprevir/ritonavir). The company anticipates potential market opportunities in the growing field of dermatology, where unmet needs for effective treatments persist.