The FDA approved Pfizer Inc's (PFE) supplemental marketing application seeking approval for Xeljanz (tofacitinib) for active ankylosing spondylitis.
- The approval covers adult patients who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.
- The approval was based on a Phase 3 trial data that evaluated the efficacy and safety of tofacitinib 5 mg twice daily versus placebo in 269 adult patients living with active ankylosing spondylitis.
- The study met its primary endpoint showing that at week 16, the percentage of patients achieving an Assessment in SpondyloArthritis international Society (ASAS)20 response was significantly greater with tofacitinib versus placebo.
- Ankylosing spondylitis, a type of arthritis that causes inflammation in certain parts of the spine.
- Xeljanz is the first and only oral JAK inhibitor approved in the U.S. in five indications.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: PFE shares are up 0.74% at $55.95 during the premarket session on the last check Wednesday.
