NORTH CHICAGO, Ill., July 29, 2026
AbbVie announced that the European Commission (EC) has approved RINVOQ® (upadacitinib) for the treatment of adults and adolescents aged 12 years and older with severe alopecia areata (AA). The approval makes RINVOQ a new treatment option for patients living with the autoimmune disease and is supported by positive results from the pivotal Phase 3 UP-AA clinical program. The studies demonstrated statistically significant scalp hair regrowth, including complete scalp hair regrowth (SALT = 0) at Week 24, making RINVOQ the first JAK inhibitor to achieve complete scalp hair regrowth versus placebo in a Phase 3 trial. The decision further strengthens AbbVie’s growing immunology portfolio and expands the availability of innovative therapies for patients with severe autoimmune disorders across Europe.
Phase 3 UP-AA Trial Demonstrates Significant Hair Regrowth
The European Commission approval is based on data from the ongoing Phase 3 UP-AA clinical program, which included two replicate, randomized, placebo-controlled, double-blind studies evaluating RINVOQ 15 mg and 30 mg once daily in 1,399 patients aged 12 to 64 years with severe alopecia areata across 248 global clinical sites. Both dose groups met the primary endpoint, with significantly more patients achieving a Severity of Alopecia Tool (SALT) score of ≤20, representing at least 80% scalp hair coverage at Week 24 compared with placebo. The studies also achieved key secondary endpoints, including complete scalp hair regrowth (SALT = 0) and clinically meaningful improvements in eyebrow and eyelash regrowth, highlighting the therapy’s ability to restore hair growth across multiple affected areas. Investigators also reported that the safety profile remained consistent with previously approved RINVOQ indications, with no new safety signals identified during the placebo-controlled treatment period.
Addressing an Important Need in Autoimmune Hair Loss
Alopecia areata is a chronic immune-mediated disease that causes unpredictable hair loss ranging from localized bald patches to complete loss of scalp and body hair. Beyond its physical symptoms, the disease is associated with significant psychological, emotional, social, and economic burden, with studies showing increased risks of depression and anxiety, particularly among women. AbbVie noted that the approval provides physicians with an additional systemic treatment option capable of delivering meaningful hair regrowth while addressing the underlying immune mechanisms responsible for disease progression. According to trial investigator Professor Thierry Passeron, the robust UP-AA results demonstrate clinically meaningful improvements in scalp, eyebrow, and eyelash regrowth within just 24 weeks, supporting the role of RINVOQ as an important new therapy for patients with severe alopecia areata across Europe.
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Expanding AbbVie’s Immunology Leadership
The latest approval further expands RINVOQ’s European indications, which already include rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, giant cell arteritis, and non-segmental vitiligo. RINVOQ is a selective and reversible JAK inhibitor discovered and developed by AbbVie and continues to be evaluated in additional Phase 3 clinical trials for diseases including hidradenitis suppurativa, Takayasu arteritis, and systemic lupus erythematosus, while its application for alopecia areata remains under U.S. FDA regulatory review. AbbVie stated that the new European approval reinforces its long-term commitment to advancing innovative therapies that address immune-mediated diseases and improve outcomes for patients living with chronic autoimmune conditions worldwide.
Source: AbbVie press release
