AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Children with Active Polyarticular Juvenile Idiopathic Arthritis

RINVOQ is now approved in the European Union for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients two years of age and older who have responded inadequately to, or who are intolerant to, one or more DMARDs 1 Approval was based on   the open-label Phase 1 SELECT-YOUTH study   and   data from adults with rheumatoid arthritis 1,2 A new oral solution of RINVOQ was approved for use in patients with pJIA 1 RINVOQ is currently approved in the European Union for 11 indications across various immune-mediated, inflammatory diseases 1 NORTH CHICAGO, Ill. , Sept. 22, 2026 / PRNewswire / -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved RINVOQ ® (upadacitinib; 15 mg tablet and weight-based 1 mg/mL oral solution) for the treatment of active polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), in patients two years of age and older who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate. 1 "The European Commission's approval of RINVOQ for pJIA expands the treatment options available to pediatric patients and their families, offering the potential for remission, improvements in pain and physical function," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "RINVOQ's new indication continues to build on our differentiated immunology portfolio with breadth and depth across therapeutic areas and patient populations." Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease of childhood and is estimated to impact approximately 126,000 children in Europe. 3 pJIA is a subtype of JIA and is characterized by inflammation in five or more joints – including the small joints of the hands and feet and large joints like the knees, hips and ankles – that persists for at least six weeks in children and adolescents. 4,5  This disease can be painful and debilitating and, if left untreated, may lead to joint damage. 3,6 Ongoing disease activity in pJIA is common, with persistent symptoms or flares affecting many patients into adulthood. 6-8 Data Supporting the EC Approval The EC approval of RINVOQ for pJIA is supported by the SELECT-YOUTH study and data from adult patients with rheumatoid arthritis. The SELECT-YOUTH study is a single-arm, open-label, global, Phase 1 study evaluating the pharmacokinetics, efficacy, safety and tolerability of RINVOQ in patients ages 2 to 1,2 RINVOQ demonstrated efficacy as early as week 12, with response rates improving through week 48, as shown below. 1,2  The efficacy observed in children with pJIA was generally consistent with responses in adult patients with rheumatoid arthritis. 1 SELECT-YOUTH Clinical Response 1 Efficacy Measure       Week 12            RINVOQ*           (N=122)            Week 48      RINVOQ* (N=122)   70% improvement of disease activity     (ACR pediatric 70 response), NRI 1   66.4%‌ 79.5%‌   Remission (JADAS27-CRP ≤1), NRI 1    23.0%‌ 43.4%‌ — Company newsroom — sourced from AbbVie. Matter furnished by the company. Not a Notice Nearby paid placement. This page reprints matter furnished by the company from its official newsroom. Notice Nearby did not write this release. Read the original: https://news.abbvie.com/2026-09-22-AbbVie-Announces-European-Commission-Approval-of-RINVOQ-R-upadacitinib-for-the-Treatment-of-Children-with-Active-Polyarticular-Juvenile-Idiopathic-Arthritis