RINVOQ (Upadacitinib) Receives Its Sixth U.S. FDA Approval

AbbVie announces that the U.S. Food and Drug Administration (FDA) has approved RINVOQ (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. 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.

“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,” said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie.  “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 FDA approval decision is supported by data from the Phase 3 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.

“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,” said Atul Deodhar, M.D., professor of medicine and medical director of the Rheumatology Clinics for the Division of Arthritis and Rheumatic Diseases at Oregon Health & Science University, and lead investigator of the SELECT-AXIS 2 nr-axSpA trial. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

“There are limited treatment options for people living with nr-axSpA, a condition that can pose many challenges for patients and significantly impact their quality of life as their symptoms persist despite treatment,” said Cassie Shafer, chief executive officer, Spondylitis Association of America (SAA). “This approval of RINVOQ is a tremendous step forward in providing our patient community with another option to help them reach their treatment goals, and to find relief.”

This FDA approval marks the sixth indication for RINVOQ in the United States across chronic immune-mediated diseases, including four in rheumatology.