AbbVie wins EU approval for RINVOQ in juvenile arthritis patients

  • AbbVie announced European Commission approval of RINVOQ for active polyarticular juvenile idiopathic arthritis.
  • SELECT-YOUTH enrolled 122 patients, with ACR Pediatric 70 response reaching 79.5% at week 48.
  • RINVOQ is approved in the European Union for 11 immune-mediated inflammatory disease indications.

AbbVie said the European Commission approved RINVOQ (upadacitinib), a selective JAK inhibitor, for active polyarticular juvenile idiopathic arthritis (pJIA) in patients aged 2 and older who responded inadequately to, or are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs). The medicine may be used alone or with methotrexate and is available as a 15 mg tablet or weight-based 1 mg/mL oral solution. The decision was supported by the open-label Phase 1 SELECT-YOUTH study and adult rheumatoid arthritis data. In 122 children, the ACR Pediatric 70 response rate rose from 66.4% at week 12 to 79.5% at week 48, while JADAS27-CRP remission increased from 23.0% to 43.4%. AbbVie reported no new safety risks, no major cardiovascular or thrombotic events, malignancies or deaths, and no negative impact on growth or development during the study. RINVOQ is now approved in the European Union for 11 indications across immune-mediated inflammatory diseases.

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