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AbbVie Says Health Canada Approves RINVOQ To Treat Adults With Active Nr-axSpA
(RTTNews) - AbbVie (ABBV) announced Tuesday that Health Canada has approved RINVOQ (upadacitinib, 15 mg), the first oral, once-daily selective and reversible JAK inhibitor for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response to a biologic disease modifying anti-rheumatic drug (DMARD) or when use of those therapies is inadvisable.
This indication follows the July 2022 Health Canada approval of RINVOQ for adults with active ankylosing spondylitis (AS) who have had an inadequate response to a biologic DMARD or when use of those therapies is inadvisable, making RINVOQ the first and only JAK inhibitor approved for the full spectrum of axial spondyloarthritis.
The approval is based on results from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which RINVOQ delivered rapid and meaningful disease control, meeting the primary endpoint of ASAS40 response at week 14 versus placebo.
RINVOQ is the first and only Janus Kinase (JAK) inhibitor approved to treat patients across the spectrum of axial spondyloarthritis (nr-axSpA and ankylosing spondylitis) in Canada.
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