Upadacitinib Receives Positive CHMP Opinion for Severe Alopecia Areata

AbbVie announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of upadacitinib (Rinvoq; 15 mg and 30 mg once daily) for the treatment of adults and adolescents with severe alopecia areata (AA). The European Commission, which makes the final regulatory decision for the European Union, is expected to issue its decision in the coming months.¹

The recommendation also marks an important milestone in the therapy's broader regulatory journey. Upadacitinib is currently under review by the FDA² after AbbVie submitted a supplemental new drug application (sNDA) in April seeking approval for the treatment of adults and adolescents with severe AA. That application is supported by the same phase 3 UP-AA clinical program that formed the basis of the CHMP's recommendation.

Although regulatory decisions are made independently, the positive CHMP opinion represents another step forward as FDA review continues².

Phase 3 Data Supported Recommendation

The CHMP opinion is based on data from the phase 3 UP-AA clinical program (M23-716), which consisted of 2 replicate, randomized, placebo-controlled, double-blind studies evaluating upadacitinib in adults and adolescents with severe AA.

Both the 15-mg and 30-mg doses met the primary end point of achieving a Severity of Alopecia Tool (SALT) score of 20 or less at week 24, demonstrating significantly greater scalp hair regrowth than placebo. Both doses also met all ranked secondary end points, including complete scalp hair regrowth (SALT = 0) at week 24. According to AbbVie, upadacitinib is the first JAK inhibitor to achieve this ranked secondary end point in the UP-AA program.

The global development program enrolled 1,399 patients aged 12 to 64 years across 248 study sites worldwide (NCT06012240).

"Alopecia areata is an unpredictable autoimmune disease with underrecognized patient burden," said Roopal Thakkar, MD, executive vice president, research and development, and chief scientific officer at AbbVie. “The CHMP's positive opinion for upadacitinib is a step closer to bringing a new treatment option to patients living with severe alopecia areata."¹

Building on Earlier Phase 3 Findings

The positive opinion follows encouraging results previously reported from the UP-AA clinical program. As Dermatology Times reported when AbbVie submitted its sNDA to the FDA in April³, 44.6% of patients receiving upadacitinib 15 mg and 54.3% receiving the 30-mg dose achieved at least 80% scalp hair coverage at week 24, compared with 3.4% of patients receiving placebo.

At the time, Amy Spizuoco, DO, dermatologist and dermatopathologist at True Dermatology and member of the Dermatology Times Editorial Advisory Board, described the findings as "a breakthrough moment in AA treatment."

"Alopecia areata, when severe and resistant to traditional treatments, is disfiguring and debilitating," Spizuoco said. "The impressive hair regrowth rates seen with upadacitinib, coupled with its favorable safety profile, mark a new standard for therapeutic efficacy in a challenging autoimmune condition that significantly impacts mental health and self-esteem."¹

Following the FDA submission, Kori Wallace, MD, PhD, vice president and global head of immunology clinical development at AbbVie, also emphasized the significance of the findings.

"In the UP-AA clinical program, upadacitinib showed early and substantial scalp hair growth, including complete scalp hair coverage, which is a significant outcome for those living with this often-overlooked disease," Wallace said.

Looking Ahead

If approved by the FDA, upadacitinib would become the fourth Janus kinase (JAK) inhibitor approved for the treatment of alopecia areata, joining baricitinib (Olumiant; Eli Lilly), ritlecitinib (Litfulo; Pfizer), and deuruxolitinib (Leqselvi; Sun Pharma).

Upadacitinib is already approved in the European Union and the United States for several immune-mediated conditions, including moderate to severe atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, Crohn disease, and giant cell arteritis. The therapy is not currently approved for alopecia areata in either region, and regulatory review remains ongoing.

References

1. AbbVie receives positive CHMP opinion for upadacitinib (Rinvoq) for the treatment of adults and adolescents with severe alopecia areata. News release. AbbVie. Published June 29, 2026. Available at: https://news.abbvie.com/2026-06-29-AbbVie-Receives-Positive-CHMP-Opinion-for-Upadacitinib-RINVOQ-R-for-the-Treatment-of-Adults-and-Adolescents-with-Severe-Alopecia-Areata
2. AbbVie submits sNDA for upadacitinib in adults and adolescents with severe alopecia areata. Dermatology Times. Published May 5, 2026. Available at: https://www.dermatologytimes.com/view/abbvie-submits-snda-for-upadacitinib-in-adults-and-adolescents-with-severe-alopecia-areata
3. Upadacitinib shows strong efficacy in second pivotal phase 3 study for severe alopecia areata. Dermatology Times. Published September 2025. Available at: https://www.dermatologytimes.com/view/upadacitinib-shows-strong-efficacy-in-second-pivotal-phase-3-study-for-severe-alopecia-areata