AbbVie bags RINVOQ FDA approval for nr-axSpA in adults

RINVOQ FDA approval for nr-axSpA : AbbVie has bagged approval for its selective JAK inhibitor RINVOQ (upadacitinib 15 mg, once daily) from the US Food and Drug Administration (FDA) for the treatment of adults having active non-radiographic axial spondyloarthritis (nr-axSpA).

The approval from the FDA is for nr-axSpA in people with objective signs of inflammation in people who did not show adequate response or who were not tolerant to tumor necrosis factor (TNF) blocker therapy.

This is now the sixth FDA approval for RINVOQ across chronic immune-mediated diseases, of which four are in rheumatology, said AbbVie.

Prior to the approval for active non-radiographic axial spondyloarthritis, RINVOQ bagged an FDA approval in April 2022 for adults having active ankylosing spondylitis (AS) who had an insufficient response or intolerance to one or more blockers of tumor necrosis factor blocker therapy.

Commenting on RINVOQ FDA approval for nr-axSpA, Thomas Hudson — AbbVie senior vice president, research and development, chief scientific officer said: “This latest FDA approval of RINVOQ in active nr-axSpA provides a new oral, once-daily treatment option for patients who historically have had limited treatment options for this painful, chronic disease.

“RINVOQ is now approved to treat patients across the spectrum of axial spondyloarthritis. This further underscores AbbVie’s commitment to advancing the standards of care for patients living with these diseases.”

RINVOQ FDA approval for nr-axSpA has been driven by the findings of the phase 3 SELECT-AXIS 2 clinical trial. Among patients subjected to RINVOQ 15 mg in the late-stage clinical trial, almost 50% achieved an ASAS40 response, which is the primary endpoint, at week 14, in comparison to placebo.

Atul Deodhar — Lead investigator of the SELECT-AXIS 2 nr-axSpA trial, commenting on RINVOQ FDA approval for nr-axSpA, said: “Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments.  In the SELECT-AXIS 2 trials, RINVOQ demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications.

“Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Recently, AbbVie acquired DJS Antibodies, a UK-based biotech company, in a deal worth $255 million, to further strengthen its immunology pipeline.