FDA approves upadacitinib for non-radiographic axial spondyloarthritis
Click Here to Manage Email Alerts
The FDA has approved upadacitinib for the treatment of non-radiographic axial spondyloarthritis, marking the sixth indication for the therapy, according to a press release from AbbVie.
“This latest FDA approval of Rinvoq in active [non-radiographic axial SpA (nr-axSpA)] provides a new oral, once daily treatment option for patients who historically have had limited treatment options for this painful, chronic disease,” Thomas Hudson, MD, senior vice president of research and development, and chief scientific officer, for AbbVie, said in the release. “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.”
The approval is specifically for once daily upadacitinib (Rinvoq, AbbVie) in the treatment of adults with active non-radiographic axial SpA with objective signs of inflammation who have demonstrated an inadequate response, or intolerance, to TNF inhibitors. This new indication follows the FDA’s approval of the drug for ankylosing spondylitis in April, making it the first and, so far, only JAK inhibitor approved for both diseases, the company said.
According to the release, the FDA’s decision was based on data from the phase 3 SELECT-AXIS 2 trial. The trial demonstrated that, among patients who received upadacitinib 15 mg, 44.9% achieved the primary endpoint of ASAS40 response at 14 weeks, compared with 22.3% of those who received placebo, the company said. Additionally, the safety profile for patients with non-radiographic axial SpA receiving upadacitinib was similar to that seen in patients with rheumatoid arthritis, AS and psoriatic arthritis who received the drug.
“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments,” Atul Deodhar, MD, of the Oregon Health & Science University, in Portland, and lead investigator of the SELECT-AXIS 2 trial, said in the release. “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.”
Click Here to Manage Email Alerts