NEW YORK--(Business Wire)--
Pfizer Inc. (NYSE: PFE) announced today that the Japanese Ministry of Health,
Labor and Welfare (MHLW) has approved XELJANZ® (tofacitinib citrate) for the
treatment of adults with rheumatoid arthritis (RA) who have had an inadequate
response to existing therapies. XELJANZ may be used in patients in whom clinical
symptoms due to the disease remain even after appropriate treatment with at
least one other disease-modifying antirheumatic drug (DMARD), such as
methotrexate. The recommended dose of XELJANZ is 5 mg twice daily.
XELJANZ will be commercially available in Japan after the National Health
Insurance listing and will be co-promoted in Japan by Pfizer and Takeda
Pharmaceutical Company Limited. Pfizer and Takeda also currently co-promote the
RA drug Enbrel® (etanercept) in Japan.
XELJANZ (ZEL` JANZ`) is the first approved oral treatment in a new class of
medicines known as Janus kinase (JAK) inhibitors. Initially, XELJANZ will be
made available in Japan to medical institutions participating in an all-patient
"RA is a serious and disabling disease and there is a need for new treatment
options, as a significant number of patients do not adequately respond to
current therapies," said Mark Swindell, Head of Pfizer Specialty Care Business
Unit in Japan. "We are proud of our strong portfolio of treatments for
inflammatory disorders in Japan, and we are pleased with the approval of
XELJANZ, which allows us to offer an additional treatment option for RA
Unlike biologic therapies that target RA outside the cell, XELJANZ targets the
disease from inside the cell. It is specifically designed to inhibit the Janus
kinase (JAK) pathways, which are signalling pathways inside the cell that play a
role in the inflammation involved in RA.
The approval of XELJANZ in Japan is supported by a multi-study, global clinical
development program, which evaluated XELJANZ in approximately 5,000 patients
across various RA patient populations. The application also included data from
Japanese subjects from two phase 2 studies, one phase 3 study and an ongoing
long-term extension study. Across five global pivotal trials, XELJANZ 5 mg twice
daily demonstrated efficacy, whether administered alone or in combination with a
non-biologic DMARD, such as methotrexate, in patients who had a previous
inadequate response to non-biologic or biologic DMARDs, including tumor necrosis
factor (TNF) inhibitors.
XELJANZ is approved for the treatment of RA patients who have had an inadequate
response to existing therapies. Notable safety findings observed in the XELJANZ
RA program include serious and other important infections, including
tuberculosis and herpes zoster; malignancies, including lymphoma;
gastrointestinal perforations; decreased neutrophil and lymphocyte counts; and
lipid elevations. The most common serious adverse events were serious
infections. The most commonly reported adverse events were upper respiratory
tract infections, headache, nasopharyngitis and diarrhea.
About Rheumatoid Arthritis
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 700,000 - 800,000 people in Japan1 and
23.7 million people worldwide.2 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.3,4,5,6,7,8 There remains a need for additional options.
Pfizer Inc.: Working together for a healthier world
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 www.pfizer.com.
1 Report from Study Committee on Rheumatoid Arthritis and Allergy Accessed on 13
2 World Health Organization, "The Global Burden of Disease, 2004 Update."
Accessed 13 March 2012. Available at
3 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.
The Lancet 2004. 363: 675-681
4 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. Arthritis & Rheumatism 2004. 50:
5 Lipsky, P, Van der Heijde, D, St. Clair, W. Infliximab and methotrexate in the
treatment of rheumatoid arthritis. The New England Journal of Medicine 2000.
6 Duclos M, Gossec L, Ruyssen-Witrand A, et al. Retention rates of tumor
necrosis factor blockers in daily practice in 770 rheumatic patients. J
Rheumatol 2006; 33:2433-8.
7 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. J Rheumatol 2006; 33(2):248-55.
8 Blum MA, Koo D, Doshi JA. Measurement and rates of persistence with and
adherence to biologics for rheumatoid arthritis: a systematic review. Clin Ther
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