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The FDA approval decision is supported by data from the Phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of RINVOQ in adults with active nr-axSpA. Among patients who received RINVOQ 15 mg, nearly half achieved an ASAS40* response, the primary endpoint, at week 14 compared to placebo (44.9 percent vs. 22.3 percent respectively).1,2 ASAS40 responses were observed as early as two weeks in nr-axSpA patients treated with RINVOQ

RINVOQ® (Upadacitinib) Receives Its Sixth U.S. FDA Approval

AbbVie (NYSE: ABBV) today announces that the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. This additional indication follows the FDA approval of RINVOQ in April of this year for adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers, making it the first and only JAK inhibitor that is approved for both conditions

By AP News
Published - Oct 21, 2022, 05:24 PM ET
Last Updated - Jul 18, 2024, 02:23 AM EDT
  • RINVOQ is now approved as the first and only oral JAK inhibitor for adults with active non-radiographic axial spondyloarthritis (nr-axSpA)
  • RINVOQ is the first and only JAK inhibitor approved for both active ankylosing spondylitis (AS) and nr-axSpA1-3
  • In a clinical study, RINVOQ delivered rapid and meaningful disease control based on patients achieving ASAS40 vs. placebo, as well as significant improvement in signs and symptoms of nr-axSpA at week 141,2
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