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U.S. FDA Approves AbbVie's RINVOQ® (upadacitinib) for Ankylosing Spondylitis (AS)

The U.S. Food and Drug Administration (FDA) has approved AbbVie’s (NYSE: ABBV) RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of adults with active ankylosing spondylitis (AS) .

Benzinga · 04/29/2022 15:52

The U.S. Food and Drug Administration (FDA) has approved AbbVie’s (NYSE:ABBV) RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of adults with active ankylosing spondylitis (AS) .

This approval is supported by efficacy and safety data from the Phase 3 SELECT-AXIS 2 clinical trial (Study 1) and the Phase 2/3 SELECT-AXIS 1 clinical trial evaluating RINVOQ.

In both SELECT-AXIS 1 and SELECT-AXIS 2 clinical trials, RINVOQ 15 mg met primary endpoint of achieving an ASAS40* response compared to those receiving placebo at week 14.

Thomas Hudson, M.D., chief scientific officer, stated, "Ankylosing spondylitis is a debilitating disease that often affects younger adults and, over time, can result in lasting structural damage that can take an emotional toll on a patient's life, This latest approval demonstrates another important step forward in our mission to advance the standards of care in rheumatic diseases.”

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

Abbvie is currently trading down 7.4 percent at $145.