FDA Approves Upadacitinib for Non-Radiographic Axial Spondyloarthritis Save

On Friday October 21st the U.S. Food and Drug Administration (FDA) approved upadacitinib (Rinvoq) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy.

Upadacitinib (UPA) was approved for nr-ax-SpA by the EMA in July of this year and was FDA approved in April 2022 for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers.  This is the 6th FDA approval for updacitinib which is also approved for use in rheumatoid arthritis, psoriatic arthritis, eczema and ulcerative colitis.

UPA is now one of four agents to be FDA approved for nr-axSpA, joining certolizumab, secukinumab, and ixekizumab.

Upadacitinib is an oral tablet approved at a dose of 15 mg, once daily.  FDA approval is based on the Phase 3 SELECT-AXIS 2 clinical trial showing UPA in adults with active nr-axSpA with nearly half achieving an ASAS40 response at week 14 compared to placebo (44.9 percent vs. 22.3 percent respectively).

The safety profile of UPA in nr-axSpA was consistent with the safety profile in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.