FDA Approves tofacitinib for Treatment of Active Ankylosing Spondylitis
NEW YORK - The U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for XELJANZ® / XELJANZ® XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) 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 of XELJANZ for AS is based on data from a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of tofacitinib 5 mg twice daily versus placebo in 269 adult patients living with active AS. 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 (56.4%, n= 75) versus placebo (29.4%, n=40) (p<0.0001). In addition, the percentage of patients achieving an ASAS40 response was significantly greater with tofacitinib (40.6%, n=54) versus placebo (12.5%, n=17) (p<0.0001), a key secondary endpoint of the study.1 ASAS20/40 are used for defining improvement or response to treatment.2 The safety profile observed in patients with AS treated with XELJANZ was consistent with the safety profile observed in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients.
"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.3 This disease often occurs in early adulthood and causes pain, swelling and possibly restricted mobility,"4 said Steven Taylor, Executive Vice President, Mission and Strategic Initiatives of the Arthritis Foundation. "With this approval, physicians and patients now have an additional oral treatment option that can help address this chronic and often progressive disease."
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