The recommendation follows results from the Phase 3 UP-AA clinical program, which evaluated 1,399 participants across 248 global sites. In these trials, patients receiving 15 mg and 30 mg doses met the primary endpoint of achieving a Severity of Alopecia Tool (SALT) score of 20 or less at week 24. Notably, the treatment also achieved the secondary endpoint of complete scalp hair regrowth, marking a significant milestone for JAK inhibitor therapies in this indication.

"Alopecia areata is an unpredictable autoimmune disease with underrecognized patient burden," said Roopal Thakkar, AbbVie’s executive vice president of research and development. While current treatment options for the condition remain limited, the potential authorization of upadacitinib—marketed as RINVOQ—aims to address the significant physical and social impact of the disease. The final regulatory decision from the European Commission is expected in the coming months.