Benzinga | Jan 7, 2022 01:04PM EST

AbbVie Reports Submission Of Applications For Upadacitinib In Non-Radiographic Axial Spondyloarthritis to FDA, European Medicines Agency

- Submissions supported by Phase 3 study in which upadacitinib (RINVOQ(r)) demonstrated significant improvements in signs and symptoms as well as physical function and disease activity versus placebo

- No new safety risks were observed compared to the known safety profile of upadacitinib

- AbbVie has also submitted results from two studies of upadacitinib in adult patients with ankylosing spondylitis (AS) to request label enhancements in the European Union (EU)

- RINVOQ is approved for use in active psoriatic arthritis (PsA), moderate to severe active rheumatoid arthritis (RA), moderate to severe atopic dermatitis (AD) and active AS in the EU, and for PsA and RA in the US

NORTH CHICAGO, Ill., Jan. 7, 2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that it has submitted applications seeking approvals for upadacitinib (RINVOQ(r), 15 mg once daily) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). The applications are supported by the Phase 3 SELECT-AXIS 2 (Study 2) clinical trial.

In the SELECT-AXIS 2 trial (Study 2), evaluating the efficacy and safety of upadacitinib in adult patients with nr-axSpA, upadacitinib met its primary and most ranked secondary endpoints.1 Treatment with upadacitinib 15 mg once daily resulted in reductions in signs and symptoms of nr-axSpA, including back pain and inflammation, as well as improvements in physical function and disease activity at week 14 versus placebo.1

"Axial spondyloarthritis is a chronic inflammatory disease affecting the spine and can cause patients, who tend to be younger adults living active lives, to suffer from debilitating pain and significantly decrease their quality of life,"2 said Thomas Hudson, M.D., senior vice president of research and development, chief scientific officer, AbbVie. "AbbVie is committed to working with the FDA and EMA to make upadacitinib available as a treatment option for patients living with this disease."

In addition, AbbVie has requested label enhancements for upadacitinib in the European Union (EU) to include adult patients with active ankylosing spondylitis (AS) who had an inadequate response to biologic disease-modifying anti-rheumatic drugs (bDMARDs), based on the results of the Phase 3 SELECT-AXIS 2 clinical trial (Study 1), as well as two-year results of the Phase 2/3 SELECT-AXIS 1 clinical trial.1,3 AbbVie also provided these data to the FDA in support of the agency's ongoing review of the supplemental New Drug Application (sNDA) for upadacitinib in AS.

The safety data observed in these patients with AS or nr-axSpA were generally consistent with the known safety profile of upadacitinib. No new safety risks were identified.1,3,4,5