Pfizer Announces FDA Approval of Supplemental Application to Expand XELJANZ® (tofacitinib citrate) Labeling to Include Additional Patient-Reported Outcomes Data for Adults with Moderately to Severely Active Rheumatoid Arthritis

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Pfizer Inc. (NYSE: PFE) announced today 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.

“The patient-reported outcomes data show the impact that XELJANZ can have on the daily lives of patients with RA, based on physical, mental and emotional measures,” said Dr. Steven Romano, senior vice president and the head of the Medicines Development Group for Pfizer Specialty Care. “Following the FDA approval of XELJANZ in November 2012, we are pleased with the agency’s decision to approve this sNDA and add to the growing body of knowledge about XELJANZ as an additional treatment option for patients with RA.”

The approval of the PRO sNDA expands the U.S. label to include the results of health-related outcome measures from three Phase 3 studies in the XELJANZ clinical development program (ORAL Solo, Scan and Step, also identified as Studies I, IV and V, respectively, in the XELJANZ label), as assessed by SF-36. The expanded U.S. label now includes results showing that, at three months, patients receiving XELJANZ 5 mg BID or XELJANZ 10 mg BID in these studies demonstrated greater improvement from baseline compared to placebo in all eight domains of the SF-36, as well as the physical component summary (PCS) and mental component summary (MCS) scores. This expands upon data already included in the U.S. label at the time of FDA approval that showed XELJANZ improved physical function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI). The U.S. label specifies that 5 mg BID is the recommended dose. The 10 mg BID dose is not approved.

XELJANZ is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well.

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Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. RA affects approximately 1.6 million Americansand 23.7 million people worldwide. Although multiple treatments are available, many patients do not adequately respond. Specifically, up to one-third of patients do not adequately respond, and about half stop responding to any particular DMARD within five years. As a result, there remains a need for additional options.

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