Pfizer Inc. (PFE) Tuesday said that the U.S. Food and Drug Administration has approved the supplemental New Drug Application for Xeljanz (tofacitinib) for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.
"We are proud to offer XELJANZ, a treatment option for ankylosing spondylitis that does not require an injection or an infusion, to treat this debilitating and chronic immuno-inflammatory disease," said Mike Gladstone, Global President, Inflammation & Immunology, Pfizer. "This regulatory approval affirms the clinical value and versatility of XELJANZ, the first and only Janus kinase (JAK) inhibitor approved for five indications in the United States for the treatment of patients with certain immuno-inflammatory conditions."
The approval was based on data from a Phase 3 trial 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, affects more than 350,000 people in the U.S. This disease often occurs in early adulthood and causes pain, swelling and possibly restricted mobility.
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