FDA Approves Rinvoq for Another Inflammatory Condition
The FDA approval in active ankylosing spondylitis is the fifth indication for Rinvoq in chronic immune-mediated diseases. It joins Xeljanz, which was the first approved JAK inhibitor for this condition in December 2021.
The FDA has approved AbbVie’s Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis, an inflammatory disease that can cause vertebrae to fuse and can lead to a hunched posture.
It is the second JAK inhibitor approved to treat this condition when patients have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The first was Pfizer’s Xeljanz (tofacitinib), which was approved in December 2021.
Atul Deodhar, M.D.
“Many patients with ankylosing spondylitis do not achieve disease control with current biologic therapies and additional treatments are needed to help relieve the signs and symptoms of this disease,” 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 investigator of the SELECT-AXIS 2 study, said in a press release.
The approval of Rinvoq for ankylosing spondylitis is supported by the phase 3 SELECT-AXIS 2 clinical trial evaluating patients who had an inadequate response or intolerance to one or two biologic disease-modifying anti-rheumatic drugs and the phase 2/3 SELECT-AXIS 1 clinical trial evaluating patients who were naïve to bDMARDs and had an inadequate response or intolerance to at least two nonsteroidal anti-inflammatory drugs.
Treatment with Rinvoq resulted in improvements in the signs and symptoms of AS, including total back pain, as well as improvements in physical function and disease activity compared with placebo at week 14. Overall, the safety profile observed in patients with active AS treated was consistent with the safety profile observed in patients with rheumatoid arthritis and psoriatic arthritis.
Rinvoq is a JAK-inhibitor that is also approved to treat severe rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and atopic dermatitis. In December 2021, the FDA required JAK inhibitors, including Rinvoq, to include on their labels the risk of cardiovascular events and cancer.
Related: FDA Requires New Boxed Warning on Xeljanz, other JAK Inhibitors
Newsletter
Get the latest industry news, event updates, and more from Managed healthcare Executive.
PBM-Offered Genomics Testing Could Reshape Prescribing of Medications
July 25th 2025Two PBMs, True Rx Health Strategies and Capital Rx, are using pharmacogenomics — how a person’s DNA affects their response to medications — to reduce the trial-and-error of prescribing medications, saving employers and patients time and money.
Read More
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
FDA Extends Review of Blenrep Combinations in Multiple Myeloma
July 24th 2025Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.
Read More
Sarepta to Pause Shipments of the Gene Therapy Elevidys
July 22nd 2025Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.
Read More
