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# FDA Approves Xeljanz for Ankylosing Spondylitis
- URL: https://www.fdaweb.com/fda-approves-xeljanz-for-ankylosing-spondylitis/
- Published: 2021-12-15T12:00:00.000Z
- Updated: 2026-09-14T17:25:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150782

FDA has approved a Pfizer supplemental NDA for its JAK inhibitor Xeljanz /Xeljanz XR (tofacitinib) for treating adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. Approval is based on data from a Phase 3 study that showed a greater percentage of Xeljanz patients achieving an Assessment in SpondyloArthritis International Society response compared with a placebo (56.4% vs 29.4%, respectively).

The supplemental NDA review action had been delayed due to an FDA safety review ([see earlier story](https://www.fdaweb.com/fda-delays-decisions-on-rinvoq-supplemental-ndas/)) of all JAK inhibitors. The drug class concerns arose from an FDA-required safety study when Xeljanz was approved in 2012 for rheumatoid arthritis. In September, FDA [ordered](https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death?utm%5Fmedium=email&utm%5Fsource=govdelivery) a drug class warning after reviewing a recent clinical trial that showed an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with Xeljanz and Xeljanz XR.