AbbVie’s Upadacitinib Cleared for European Approval in Alopecia Areata

The recommendation follows results from the Phase 3 UP-AA clinical program, which evaluated 15 mg and 30 mg doses of the drug. In these trials, patients achieved significant scalp hair regrowth, meeting the primary endpoint of a Severity of Alopecia Tool score of 20 or less by week 24. Notably, the treatment also demonstrated efficacy in improving eyebrow and eyelash coverage, marking a potential shift in care for a disease often dismissed as merely cosmetic.

Roopal Thakkar, AbbVie’s executive vice president of research and development, noted that the opinion represents a meaningful step toward addressing the underrecognized burden of the disease. While the European Commission must still grant final approval, the drug is already established in the EU for several other inflammatory conditions, including atopic dermatitis and rheumatoid arthritis. The company expects a final decision in the coming months, following global trials that involved 1,399 participants across 248 study sites.