ICYMI: EU Approves Upadacitinib for Severe Alopecia as US Review Remains Pending

The European Commission has approved upadacitinib (RINVOQ; AbbVie) for adults and adolescents 12 years and older with severe alopecia areata (AA), making it the latest systemic option available to European clinicians treating this immune-mediated form of hair loss.¹ The approval, announced July 29, 2026, applies to both the 15 mg and 30 mg once-daily doses and is based on the phase 3 UP-AA program. In the US, the drug remains under regulatory review, with a decision still pending months after AbbVie's submission.

What the EU Approval Is Based On

The EU decision rests on data from two replicate, randomized, double-blind, placebo-controlled studies (Study 1 and Study 2) that together enrolled 1,399 participants ages 12 to 64 with severe AA across 248 global sites. Both doses met the primary endpoint—a Severity of Alopecia Tool (SALT) score of 20 or lower, corresponding to at least 80% scalp coverage, at week 24—with significantly more responders than placebo. Key secondary endpoints were also met, including complete scalp hair regrowth (SALT = 0), along with improvements in eyebrow and eyelash regrowth. AbbVie has highlighted upadacitinib as the first JAK inhibitor to demonstrate complete scalp regrowth versus placebo at week 24 in a pivotal program. The safety profile through this period was described as consistent with upadacitinib's established indications.

"Alopecia areata is a complex condition to treat often due to its unpredictable disease course and prognosis," said Thierry Passeron, MD, PhD, professor and chair of the department of dermatology at the Université Côte d'Azur in Nice, France. "The UP-AA results based on stringent endpoints demonstrated clinically meaningful scalp hair regrowth and improvements in eyebrows and eyelashes in 24 weeks, supporting RINVOQ as an important new treatment option for severe alopecia areata patients in Europe."

Where the US Stands: Data Recap

Unlike the EU, the US has not yet approved upadacitinib for AA. AbbVie submitted a supplemental new drug application (sNDA) to the FDA in April 2026, based on the same UP-AA program now supporting the EU approval.² If cleared by the FDA, upadacitinib would become the fourth JAK inhibitor approved in the US for severe AA, following baricitinib (Olumiant; Eli Lilly) in June 2022, ritlecitinib (Litfulo; Pfizer) in June 2023, and deuruxolitinib (Leqselvi; Sun Pharma) in June 2024.

The UP-AA program (NCT06012240) was conducted under a single protocol but analyzed independently.³ Each included a 24-week double-blind, placebo-controlled period (Period A), followed by a blinded extension through week 52 (Period B), during which placebo-treated patients with an adequate week-24 response could continue on placebo or be re-randomized based on their SALT score. The enrolled population had substantial baseline disease burden, with a mean SALT score of 84 and roughly half of participants at a SALT score of 95 or higher, indicating near-total or total scalp hair loss.

At week 24, SALT ≤20 was achieved by 45.2% and 44.6% of patients on the 15 mg dose in Studies 1 and 2, respectively, versus 1.5% and 3.4% on placebo. The 30 mg dose produced response rates of 55.0% and 54.3%. Response rates continued to climb through week 52, reaching roughly 55% to 64% across doses. Complete scalp regrowth (SALT = 0) at week 24 was reported in 14.1% and 13.1% of patients on the 15 mg dose and 20.3% and 22.5% on the 30 mg dose, compared with 0% and 0.7% on placebo; by week 52, complete regrowth rates rose to roughly 27% to 37% across doses.

Safety findings across all studies were consistent with upadacitinib's known profile in its other approved indications, such as atopic dermatitis and rheumatoid arthritis. Serious treatment-emergent adverse events were infrequent (1.4% with 15 mg and 2.8% with 30 mg), and discontinuations were low. The most commonly reported adverse effects were acne, nasopharyngitis, and upper respiratory tract infections. As with other JAK inhibitors, upadacitinib carries boxed warnings covering infection, malignancy, major adverse cardiovascular events, thrombosis, and mortality.

What Comes Next

An ongoing long-term extension study (Study 3) is following patients who completed either pivotal trial for up to 108 weeks to assess durability of response and long-term safety, data that will likely inform both the pending FDA decision and future clinical use. For now, US clinicians treating severe AA continue to have baricitinib, ritlecitinib, and deuruxolitinib available, while upadacitinib's US availability awaits the outcome of FDA review.

For the latest clinical updates in alopecia, click here.

References

1. AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults and Adolescents with Severe Alopecia Areata. News release. AbbVie. Published July 29, 2026. Accessed August 6, 2026. https://news.abbvie.com/2026-07-29-AbbVie-Announces-European-Commission-Approval-of-RINVOQ-R-upadacitinib-for-the-Treatment-of-Adults-and-Adolescents-with-Severe-Alopecia-Areata

2. AbbVie submits application to FDA for upadacitinib (Rinvoq) for adults and adolescents with severe alopecia areata. News release. AbbVie. Published April 28, 2026. Accessed August 6, 2026. https://news.abbvie.com/2026-04-28-AbbVie-Submits-Application-to-FDA-for-Upadacitinib-RINVOQ-R-for-Adults-and-Adolescents-with-Severe-Alopecia-Areata

3. AbbVie announces positive topline results from phase 3 UP-AA trial evaluating upadacitinib (RINVOQ) for alopecia areata. News release. AbbVie. Published July 30, 2025. Accessed August 6, 2026. https://news.abbvie.com/2025-07-30-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-UP-AA-Trial-Evaluating-Upadacitinib-RINVOQ-R-for-Alopecia-Areata