The European Commission approved AbbVie’s RINVOQ (upadacitinib) to treat severe alopecia areata in adults and adolescents aged 12 and older. This decision makes RINVOQ the first JAK inhibitor approved for this autoimmune disorder in the European Union. The approval covers once-daily oral doses of 15 mg and 30 mg.
Two Phase 3 clinical trials demonstrated statistically significant scalp hair regrowth. A substantial number of patients achieved at least 80% scalp hair coverage at 24 weeks. Some patients achieved complete hair regrowth compared to the placebo group. This systemic treatment option addresses a condition characterized by significant hair loss and psychological distress.