Health
AbbVie Submits Application to FDA for Upadacitinib (RINVOQ®) for Adults and Adolescents with Severe Alopecia Areata
AbbVie (NYSE: ABBV) today announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) for the treatment of adult and adolescent patients with severe alopecia areata (AA), based on results from the Phase 3 UP-AA clinical program.1-3
About this update from Abbvie Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"Submission is supported by data from the Phase 3 UP-AA clinical program in which upadacitinib achieved the primary endpoint of severity of alopecia tool (SALT) score ≤ 20 at week 24, with additional efficacy results observed at week 521-3","length":238,"tagName":"p"}]},{"val":[{"type":"text","content":"Upadacitinib is also the first JAK inhibitor to meet the ranked secondary endpoint of complete scalp hair regrowth (SALT = 0) at week 241-3","length":139,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":377,"olType":false},{"type":"text","content":"NORTH CHICAGO, Ill., April 28, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) for the treatment of adult and adolescent patients with severe alopecia areata (AA), based on results from the Phase 3 UP-AA clinical program.1-3","length":394,"tagName":"p"},{"type":"text","content":""Alopecia areata is a chronic immune-mediated disease in which the physical and psychological burden patients can experience goes far beyond hair loss, impacting their day-to-day lives," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "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."","length":528,"tagName":"p"},{"type":"text","content":"UP-AA Clinical Trial Summary1-3UP-AA includes two replicate studies with Period A as a double-blind, placebo-controlled phase for 24 weeks, followed by Period B, a blinded extension through 52 weeks. Results from Period B are summarized descriptively.","length":252,"tagName":"p"},{"type":"text","content":"The mean baseline SALT score across the trials was 84 and approximately 51% of patients (n=716 out of 1,399) had SALT score ≥ 95 at baseline, representing a population with near-total or total scalp hair loss. SALT ≤ 20 (primary endpoint) and SALT = 0 (key ranked secondary endpoint) were met at week 24 for both upadacitinib doses (15 mg and 30 mg) and response rates improved through week 52 as shown below.","length":409,"tagNam...