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

<0> Pfizer Inc.Media Contact:Kim BenckerM: 610-329-1340E: orInvestor Contact:Suzanne HarnettO: 212-733-8009E: </0>

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.

For full prescribing information, including boxed warning and Medication Guide, please visit

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.

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at .

# # # # #

Sacks, J., Lou, Y., Helmick, C. Prevalence of Specific Types of Arthritis and Other Rheumatic Conditions in the Ambulatory Health Care System in the United States 2001-2005. . 2010. 62(4): 460-464

Howden, L., Meyer, J., 2010 U.S. Census Bureau results --- U.S.Census Bureau,

World Health Organization, “The Global Burden of Disease, 2004 Update.” Accessed 13 March 2012. Available at .

Klareskog L, Van der Heijde D, de Jager J, et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomized controlled trial. 2004. 363: 675-681.

Keystone, E, Kavanaugh A, Sharp J, et al. Radiographic, clinical and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy. 2004. 50: 1400-1411.

Lipsky, P, Van der Heijde, D, St. Clair, W. Infliximab and methotrexate in the treatment of rheumatoid arthritis. 2000. 1594-1602.

Duclos M, Gossec L, Ruyssen-Witrand A, et al. Retention rates of tumor necrosis factor blockers in daily practice in 770 rheumatic patients. 2006; 33:2433-8.

Maradit-Kremers H, Nicola PJ, Crowson CS, et al. Patient, disease, and therapy-related factors that influence discontinuation of disease-modifying antirheumatic drugs: a population-based incidence cohort of patients with rheumatoid arthritis. 2006; 33(2):248-55.

Blum MA, Koo D, Doshi JA. Measurement and rates of persistence with and adherence to biologics. for rheumatoid arthritis: a systematic review. 2011;33(7):901-913.

Suggested Articles

Support for specialty therapies with a tech-based platform that challenges the old hub model and improves the patient journey.

Eli Lilly is closing down its U.K.-based Erl Wood neuroscience in Surrey, leading to cuts and relocations.

After being hailed as a near mystic when it came to stock picks, Britain’s once great oak has been cut down to a sapling as Neil Woodford gets the ax.