AbbVie seeks FDA approval for upadacitinib in severe alopecia areata

AbbVie has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for upadacitinib (Rinvoq) for the treatment of severe alopecia areata (AA) in adults and adolescents aged 12 years and older. The application, announced April 28, 2026, is based on results from the phase 3 UP-AA clinical program, which evaluated upadacitinib at 15-mg and 30-mg once-daily doses.¹

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

Trial design and efficacy results

The UP-AA program (NCT06012240) comprises 2 replicate pivotal studies conducted under a single protocol, enrolling a total of 1399 participants aged 12 to 63 years across 248 sites worldwide.¹ Period A was a 24-week double-blind, placebo-controlled phase, followed by Period B, a blinded extension through week 52. The study population had severe disease, with a mean baseline Severity of Alopecia Tool (SALT) score of 84, and approximately 51% of patients had SALT scores of 95 or higher at baseline, indicating near-total or total scalp hair loss.¹

Guess the Diagnosis: Patches of hair loss on scalp

The primary end point was achievement of SALT score 20 or lower (representing ≥80% scalp hair coverage) at week 24. In Study 1, 45.2% of patients receiving upadacitinib 15 mg and 55.0% receiving upadacitinib 30 mg achieved this endpoint, compared with 1.5% for placebo. Results in Study 2 were consistent, with 44.6% and 54.3% response rates for the 15-mg and 30-mg doses, respectively, vs 3.4% for placebo.¹

A key ranked secondary end point was complete scalp hair regrowth (SALT = 0). According to AbbVie, upadacitinib is the first Janus kinase (JAK) inhibitor to meet this endpoint at week 24, with 14.1% and 20.3% of patients achieving complete regrowth in Study 1 (15 mg and 30 mg, respectively) and 13.1% and 22.5% in Study 2.¹ Response rates continued to improve through week 52, with SALT 20 or lower achieved by approximately 55% to 64% of patients across both doses and studies.

The safety profile through week 52 was reported to be consistent with that observed at week 24 and with the known safety profile of upadacitinib across its approved indications.¹

Clinical context

Alopecia areata is a chronic autoimmune disease characterized by unpredictable hair loss ranging from patchy scalp involvement to complete loss of all body hair.² The condition carries a substantial psychological burden, including stigma, anxiety, and depression, which is frequently underestimated when the disease is dismissed as a cosmetic concern.³ Severe AA, defined by extensive scalp hair loss, represents a particularly challenging subset with limited therapeutic options.

At the time of writing, 3 JAK inhibitors boast indications for adults with severe alopecia areata, with the FDA approving baricitinib (Olumiant), ritlecitinib (Litfulo), and deuroxolitinib (Leqselvi) in June 2022, June 2023, and July 2024, respectively.

Drug background and next steps

Upadacitinib is an oral selective JAK-1 inhibitor already approved in the United States for multiple immune-mediated inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, ulcerative colitis, Crohn disease, and giant cell arteritis.¹ The drug carries a boxed warning for serious infections, malignancies, major adverse cardiovascular events, thrombosis, and mortality risk, consistent with the JAK inhibitor class.

The week 52 data from Period B are descriptive only, as the placebo-controlled comparison ended at week 24. Long-term efficacy durability and safety beyond 52 weeks remain to be characterized, although a third study period extending up to 108 weeks is ongoing. The application is also under review by the European Medicines Agency.¹

References

1. AbbVie. AbbVie submits application to FDA for upadacitinib (Rinvoq) for adults and adolescents with severe alopecia areata. News release. 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. Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: part I. Clinical picture, histopathology, and pathogenesis. J Am Acad Dermatol. 2010;62(2):177-188.
3. Davey L, Clarke V, Jenkinson E. Living with alopecia areata: an online qualitative survey study. Br J Dermatol. 2019;180(6):1377-1389.
4. US Food and Drug Administration. FDA approves first systemic treatment for alopecia areata. June 13, 2022. Accessed April 28, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-systemic-treatment-alopecia-areata