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Pfizer Inc Announces FDA Approval Of Supplemental Application to Expand XELJANZ


Monday, 18 Nov 2013 04:47pm EST 

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for XELJANZ (tofacitinib citrate) to include additional Patient-Reported Outcomes (PRO) data in the label. These additional data show improvement in patients receiving XELJANZ based on health-related outcome measures reported by patients, including vitality, role emotional, physical function, bodily pain, social function, mental health, role physical and general health, which are the eight domains of the Medical Outcomes Study Short-Form (36-Item) Health Survey (SF-36). XELJANZ 5 mg twice-daily (BID) was approved by the FDA in November 2012 for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX), and is the first approved RA treatment in the U.S. in a new class of medicines known as Janus kinase (JAK) inhibitors. In the U.S., XELJANZ may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). XELJANZ should not be used in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine. 

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