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FDA Approves AbbVie's Rinvoq To Treatment Active Ankylosing Spondylitis

The U.S. Food and Drug Administration has approved AbbVie's (ABBV) Rinvoq (upadacitinib; 15 mg, once daily) for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.

The FDA approval was supported by efficacy and safety data from the Phase 3 SELECT-AXIS 2 clinical trial evaluating RINVOQ in patients who had an inadequate response or intolerance to one or two biologic disease-modifying anti-rheumatic drugs and the Phase 2/3 SELECT-AXIS 1 clinical trial evaluating RINVOQ in patients who were naïve to bDMARDs and had an inadequate response or intolerance to at least two nonsteroidal anti-inflammatory drugs.

Active Ankylosing spondylitis is a chronic inflammatory musculoskeletal disease primarily affecting the spine and characterized by debilitating symptoms of inflammatory back pain, stiffness and restricted mobility.

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