FDA has approved Rinvoq ,once daily, an oral therapy, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA).- AbbVie

 This additional indication follows the FDA approval of Rinvoq in April of this year for adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers, making it the first and only JAK inhibitor that is approved for both conditions.

Nr-axSpA is a chronic, progressive inflammatory rheumatic disease that causes joint inflammation, leading to back pain and stiffness, and cannot be detected by x-ray.Nr-axSpA and AS are two sub-types of a broader condition called axial spondyloarthritis. Approximately five percent of patients with nr-axSpA will progress to AS after five years, and 19 percent will progress after ten years.

The FDA approval decision is supported by data from the Phase III SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of Rinvoq in adults with active nr-axSpA. Among patients who received Rinvoq 15 mg, nearly half achieved an ASAS40 response, the primary endpoint, at week 14 compared to placebo (44.9 percent vs. 22.3 percent respectively). ASAS40 responses were observed as early as two weeks in nr-axSpA patients treated with Rinvoq. The safety profile in patients with nr-axSpA treated with Rinvoq 15 mg was consistent with the safety profile in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.