AbbVie Files sNDA for Upadacitinib in Severe Alopecia Areata

AbbVie has submitted a supplemental new drug application to the FDA seeking approval of upadacitinib (RINVOQ; 15 mg and 30 mg once daily) for adult and adolescent patients with severe alopecia areata (AA). The filing broadens the indication set for an already multi-approved JAK inhibitor, signaling that regulatory affairs teams should begin tracking the FDA review clock and preparing for potential label revisions, while manufacturing and supply chain functions assess capacity against a growing patient population.

The submission is supported by the Phase 3 UP-AA program (protocol M23-716), comprising two replicate, randomized, double-blind, placebo-controlled pivotal studies. The mean baseline SALT score across trials was 84, and approximately 51% of the 1,399 enrolled patients presented with a SALT score of 95 or above, indicating near-total or total scalp hair loss. Both doses met the primary endpoint of SALT score of 20 or below at week 24:

• Upadacitinib 15 mg: 45.2% (Study 1) and 44.6% (Study 2) vs. 1.5% and 3.4% placebo
• Upadacitinib 30 mg: 55.0% (Study 1) and 54.3% (Study 2) vs. same placebo arms

Complete scalp hair regrowth (SALT = 0), a ranked secondary endpoint, was also achieved at week 24 across both doses and both studies, with response rates continuing to improve through week 52 in the blinded extension period.

AbbVie notes that the safety profile observed through week 52 was consistent with findings at week 24 and with previously disclosed data across upadacitinib's existing indications. Use in alopecia areata remains unapproved; the application is also under review by the European Medicines Agency. Plant heads and QA directors familiar with upadacitinib's existing GMP manufacturing footprint should note that a positive FDA action would require validated processes and release testing protocols to support an expanded patient population, including adolescents, a demographic that may carry distinct formulation and labeling considerations under 21 CFR Part 211.

Source: AbbVie News Center, April 28, 2026. Clinical data referenced from the Phase 3 UP-AA program (Studies 1 and 2). All efficacy figures use non-responder imputation (NRI).