Upadacitinib sNDA Submitted to FDA for Severe Alopecia Areata

AbbVie announced on April 28, 2026, the submission of a supplemental new drug application to the US Food and Drug Administration (FDA) for upadacitinib (Rinvoq) for the treatment of severe alopecia areata in adult and adolescent patients.¹

The upadacitinib FDA submission for alopecia areata is supported by a pair of replicate phase 3 studies from the UP-AA clinical program evaluating 15 mg and 30 mg once-daily doses.

"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," Kori Wallace, MD, PhD, vice president and global head of immunology clinical development at AbbVie, said in a statement.¹

If approved, upadacitinib would become the second JAK inhibitor available for alopecia areata in the United States, joining baricitinib (Olumiant), which received FDA approval for severe alopecia areata in 2022. According to AbbVie, upadacitinib is the first JAK inhibitor to meet a ranked secondary endpoint of complete scalp hair regrowth, defined as a Severity of Alopecia Tool (SALT) score of 0, at Week 24 in a phase 3 program.¹

UP-AA Phase 3 Trial Design and Primary Efficacy Results

The UP-AA program (NCT06012240) comprises two replicate, randomized, double-blind, placebo-controlled phase 3 studies conducted across 248 sites worldwide.¹ The trials enrolled 1,399 participants aged 12 to 63 with severe alopecia areata. Mean baseline SALT score across both studies was 84, and approximately 51% of participants (716 of 1,399) had SALT scores of 95 or higher at baseline, indicating near-total or total scalp hair loss.¹

In Period A, participants were randomized to upadacitinib 15 mg, upadacitinib 30 mg, or placebo for 24 weeks. Period B extended the blinded treatment through Week 52, with descriptive reporting of results.¹

Upadacitinib met the primary endpoint of SALT score of 20 or lower at Week 24 in both studies using nonresponder imputation. In Study 1, 45.2% of patients receiving upadacitinib 15 mg and 55.0% receiving 30 mg achieved SALT of 20 or lower, compared with 1.5% on placebo.¹ Study 2 results were concordant: 44.6% for the 15 mg dose and 54.3% for the 30 mg dose versus 3.4% for placebo.¹ Response rates continued to improve through Week 52, reaching 59.3% and 63.8% for the 15 mg and 30 mg groups in Study 1 and 55.0% and 63.3% in Study 2, respectively.¹

Complete Scalp Hair Regrowth, Safety Profile, and Regulatory Outlook

On the key ranked secondary endpoint of complete scalp hair coverage (SALT = 0) at Week 24, upadacitinib 15 mg and 30 mg demonstrated clear separation from placebo in both studies. In Study 1, 14.1% of patients on 15 mg and 20.3% on 30 mg achieved SALT of 0, compared with 0% on placebo.¹ In Study 2, corresponding rates were 13.1% and 22.5% versus 0.7%.¹ By Week 52, complete scalp hair regrowth rates rose to 28.5% and 35.8% in Study 1 and 26.6% and 37.0% in Study 2 for the 15 mg and 30 mg doses, respectively.¹

According to AbbVie, the safety profile of upadacitinib 15 mg and 30 mg through Week 52 was consistent with observations at Week 24 and with previously reported data.¹ The company did not disclose new safety signals in this announcement. The class-level boxed warning for JAK inhibitors, which includes risks of serious infections, malignancy, major adverse cardiovascular events, thrombosis, and mortality, applies to the existing upadacitinib label across its approved indications.²

The application is also under review by the European Medicines Agency.¹ AbbVie is additionally studying upadacitinib in phase 3 trials for hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.¹

REFERENCES:

1. AbbVie. AbbVie submits application to FDA for upadacitinib (Rinvoq) for adults and adolescents with severe alopecia areata. Published April 28, 2026. Accessed April 28, 2026. https://www.prnewswire.com/news-releases/abbvie-submits-application-to-fda-for-upadacitinib-rinvoq-for-adults-and-adolescents-with-severe-alopecia-areata-302754816.html

2. Rinvoq [package insert]. North Chicago, IL: AbbVie Inc.; 2025.