European Commission approves upadacitinib for three immune-mediated diseases

The European Commission has approved new indications for the JAK inhibitor upadacitinib to treat three immune-mediated diseases. According to AbbVie, the authorization covers severe alopecia areata and non-segmental vitiligo in adults and adolescents aged 12 and older, as well as active polyarticular juvenile idiopathic arthritis in patients from two years of age who have shown inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.

For non-segmental vitiligo, the approval is based on Phase III Viti-Up clinical trials. Results showed that a 15 mg daily dose achieved significant skin repigmentation compared to a placebo after 48 weeks. This makes upadacitinib the first authorized systemic treatment for non-segmental vitiligo in the European Union.