AbbVie (ABBV) said Tuesday it filed regulatory applications with the US Food and Drug Administration and the European Medicines Agency for upadacitinib to treat adults and adolescents with vitiligo, an autoimmune skin condition.
In a phase 3 trial, participants achieved a 50% improvement in total body pigment, and about 75% showed facial re-pigmentation, the company said.
Currently, there are no approved systemic drugs available to help stabilize the disease or restore skin color for the approximately 84% of patients with the non-segmental form of the disorder, AbbVie said.
Common side effects reported during the trials included acne and respiratory infections, with no new safety risks identified, it added.