AbbVie (NYSE:ABBV) has submitted applications asking for approval of upadacitinib (Rinvoq) from the FDA and the European Medicines Agency (EMA) to treat adults with active non-radiographic axial spondyloarthritis (nr-axSpA). If approved, Rinvoq would be indicated for nr-axSpA patients with objective signs of inflammation with an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).
The Janus kinase (JAK) inhibitor Rinvoq recently won FDA approval for an active psoriatic arthritis indication.
FDA first approved Rinvoq for moderate to severe rheumatoid arthritis in 2019.
For the potential nr-axSpA indication, AbbVie filed positive data from the Phase 3 SELECT-AXIS 2 study.
“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,” said Dr. Thomas Hudson, M.D., senior vice president of research and development, chief scientific officer, AbbVie, in a statement. “AbbVie is committed to working with the FDA and EMA to make upadacitinib available as a treatment option for patients living with this disease.”
AbbVie is also asking to allow the use of Rinvoq for adults with active ankylosing spondylitis (AS) who had an inadequate response to biologic disease-modifying anti-rheumatic drugs (bDMARDs).
In 2020, Rinvoq raked in $731 million in net revenues internationally.