The European Commission has approved AbbVie's (NYSE: ABBV) Rinvoq (upadacitinib) for the treatment of severe alopecia areata (AA) in adults and adolescents 12 years and older, the company announced July 29, 2026.

Rinvoq is available in 15 mg and 30 mg once-daily doses for the indication. The approval is based on data from the Phase 3 UP-AA clinical program, which included two randomized, placebo-controlled, double-blind studies enrolling 1,399 participants with severe AA across 248 sites worldwide.

Both doses met the primary endpoint of a Severity of Alopecia Tool (SALT) score of 20 or below at week 24, reflecting at least 80% scalp hair coverage. Key secondary endpoints were also met in both studies, including complete scalp hair regrowth, defined as a SALT score of zero, at week 24. AbbVie claims Rinvoq is the first JAK inhibitor to achieve complete scalp hair regrowth versus placebo at that timepoint. Improvements in eyebrows and eyelashes were also reported.

The safety profile observed in the trials was described as generally consistent with Rinvoq's profile in previously approved indications. Known risks associated with the drug include serious infections, malignancy, major adverse cardiovascular events, venous thromboembolism, and others. The drug is contraindicated in patients with active tuberculosis, severe hepatic impairment, and during pregnancy.

Rinvoq is also under regulatory review by the U.S. Food and Drug Administration for the alopecia areata indication.

The drug is already approved in the EU for multiple other conditions, including atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease, and non-segmental vitiligo, among others.