NORTH CHICAGO, Ill., June 29, 2026
AbbVie has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of RINVOQ® (upadacitinib) for the treatment of adults and adolescents with severe alopecia areata (AA). The recommendation represents a significant regulatory milestone for the company and moves the oral Janus kinase (JAK) inhibitor one step closer to becoming a new treatment option for patients living with this unpredictable autoimmune disease. The positive opinion is supported by robust data from the Phase 3 UP-AA clinical program, where both the 15 mg and 30 mg once-daily doses successfully achieved the primary endpoint of Severity of Alopecia Tool (SALT) score ≤20 at Week 24 while also meeting all key secondary endpoints. Notably, RINVOQ® became the first JAK inhibitor to achieve the rigorous ranked secondary endpoint of complete scalp hair regrowth (SALT=0) in pivotal clinical studies. If approved by the European Commission, the therapy could provide a highly effective oral treatment option for patients experiencing severe hair loss caused by alopecia areata, a condition that can have profound physical and psychological consequences.
Phase 3 UP-AA Program Demonstrates Significant Hair Regrowth
The CHMP positive opinion is based on findings from the ongoing Phase 3 UP-AA clinical program, which consists of two replicate, randomized, placebo-controlled, double-blind pivotal studies evaluating the efficacy and safety of upadacitinib in adults and adolescents with severe alopecia areata. Across both studies, the 15 mg and 30 mg doses successfully met the primary endpoint by enabling significantly more patients to achieve at least 80% scalp hair coverage (SALT ≤20) compared with placebo after 24 weeks of treatment.
The studies also achieved all major secondary endpoints, including complete scalp hair regrowth (SALT=0), making RINVOQ® the first JAK inhibitor to demonstrate this level of efficacy in severe alopecia areata. The clinical program enrolled 1,399 participants aged 12 to 64 years across 248 clinical sites worldwide, providing one of the largest datasets generated for this disease. Importantly, the therapy demonstrated a safety profile generally consistent with its established use across approved inflammatory indications, reinforcing confidence in its benefit-risk profile.
Innovative JAK Inhibition Addresses an Unmet Need in Autoimmune Hair Loss
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Alopecia areata is a chronic autoimmune disease that causes partial or complete hair loss affecting the scalp, eyebrows, eyelashes, face, and body. Although often misunderstood as a cosmetic condition, the disease frequently carries substantial emotional, psychological, and social consequences that significantly reduce quality of life. RINVOQ® (upadacitinib) is an oral selective JAK inhibitor discovered and developed by AbbVie to target inflammatory signaling pathways involved in immune-mediated diseases. The therapy is already approved in the European Union for several chronic inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, Crohn’s disease, ulcerative colitis, axial spondyloarthritis, and giant cell arteritis.
The latest Phase 3 data further expand its clinical potential by demonstrating robust efficacy in severe alopecia areata while maintaining a well-characterized safety profile. If approved, the therapy could offer patients a convenient oral treatment capable of delivering meaningful and sustained scalp hair regrowth while addressing a major unmet need in autoimmune dermatology.
European Approval Could Expand Access to Advanced Dermatology Care
The CHMP recommendation represents another important milestone in AbbVie’s expanding immunology portfolio, reflecting the company’s continued investment in developing innovative therapies for immune-mediated diseases with significant unmet medical needs. The European Commission is expected to issue its final regulatory decision in the coming months. Approval would enable physicians across Europe to offer RINVOQ® as a new treatment option for adults and adolescents living with severe alopecia areata who require systemic therapy.
As scientific understanding of autoimmune disorders continues to advance, therapies capable of restoring hair growth while improving patient quality of life are becoming increasingly important. The positive CHMP opinion reinforces the growing role of precision immunology in dermatology and highlights AbbVie’s commitment to expanding treatment options through clinically validated innovation.
Source: AbbVie press release
