FDA has approved AbbVie’s Rinvoq (upadacitinib) for adults with active non-radiographic axial spondyloarthritis (nr-axSpA).
The indication covers nr-axSpA patients with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) inhibitors.
The JAK1 selective inhibitor Rinvoq now has six U.S. indications.
The new indication makes Rinvoq the only JAK inhibitor approved for adults with nr-axSpA.
To win the latest indication, Abbott submitted data from the Phase 3 SELECT-AXIS 2 clinical study focusing on adults with active nr-axSpA. The placebo-controlled study found that almost half of the recipients of Rinvoq 15 mg had achieved at least 40% improvement based on the Assessment in SpondyloArthritis International Society scale (ASAS40) at week 14. ASAS40 was the primary endpoint.
The safety profile of Rinvoq was similar in the nr-axSpA demographic to earlier Rinvoq trials involving patie…