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
NEW YORK -- November 18, 2013
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.
*It is not known if XELJANZ is safe and effective in people with Hepatitis
B or C.
*XELJANZ is not for people with severe liver problems.
*It is not known if XELJANZ is safe and effective in children.
Important Safety Information
*XELJANZ can lower the ability of the immune system to fight infections.
Some people have serious infections while taking XELJANZ, including
tuberculosis (TB), and infections caused by bacteria, fungi, or viruses
that can spread throughout the body. Some people have died from these
infections. Healthcare providers should test patients for TB before
starting XELJANZ, and monitor them closely for signs and symptoms of TB
and other infections during treatment. People should not start taking
XELJANZ if they have any kind of infection unless their healthcare
provider tells them it is okay.
*XELJANZ may increase the risk of certain cancers by changing the way the
immune system works. Lymphoma and other cancer can happen in patients
*Some people taking XELJANZ get tears in their stomach or intestines.
Patients should tell their healthcare provider right away if they have
fever and stomach-area pain that does not go away, or a change in bowel
*XELJANZ can cause changes in certain lab test results including low blood
cell counts, increases in certain liver tests, and increases in
cholesterol levels. Healthcare providers should do blood tests before
starting patients on XELJANZ and while they are taking XELJANZ, to check
for these side effects. Normal cholesterol levels are important to good
heart health. Healthcare providers may stop XELJANZ treatment because of
changes in blood cell counts or liver test results.
*Patients should tell their healthcare providers if they plan to become
pregnant or are pregnant.
It is not known if XELJANZ will harm an unborn baby. To monitor the
outcomes of pregnant women exposed to XELJANZ, a registry has been
established. Physicians are encouraged to register patients and pregnant
women are encouraged to register themselves by calling 1-877-311-8972.
*Patients should tell their healthcare providers if they plan to breastfeed
or are breastfeeding. Patients and their healthcare provider should decide
if they will take XELJANZ or breastfeed. They should not do both.
*In carriers of the hepatitis B or C virus (viruses that affect the liver),
the virus may become active while using XELJANZ. Healthcare providers may
do blood tests for hepatitis before and during treatment with XELJANZ.
*Common side effects include upper respiratory tract infections (common
cold, sinus infections), headache, diarrhea, and nasal congestion, sore
throat, and runny nose (nasopharyngitis).
For full prescribing information, including boxed warning and Medication
Guide, please visit www.XELJANZ.com.
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 1.6 million Americans^1,2
and 23.7 million people worldwide.^3 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.^4,5,6,7,8,9 As a result,
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.
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DISCLOSURE NOTICE: The information contained in this release is as of November
18, 2013. Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or future events or
This release contains forward-looking information about XELJANZ (tofacitinib
citrate), including its potential benefits, that involves substantial risks
and uncertainties. Such risks and uncertainties include, among other things,
uncertainties related to the extent of market acceptance in the U.S.; whether
and when the FDA will assess the benefit: risk profile of the 10 mg
twice-daily dose and the impact of XELJANZ on the inhibition of structural
damage; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s
Annual Report on Form 10-K/A for the fiscal year ended December 31, 2012, and
in its reports on Form 10-Q and Form 8-K.
^1 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. Arthritis Care and Research. 2010. 62(4): 460-464
^2 Howden, L., Meyer, J., 2010 U.S. Census Bureau results --- U.S.Census
Bureau, 2010 Census Summary File 1.
^3 World Health Organization, “The Global Burden of Disease, 2004 Update.”
Accessed 13 March 2012. Available at
^4 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.
^5 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:
^6 Lipsky, P, Van der Heijde, D, St. Clair, W. Infliximab and methotrexate in
the treatment of rheumatoid arthritis. The New England Journal of Medicine
^7 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.
^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. J Rheumatol 2006; 33(2):248-55.
^9 Blum MA, Koo D, Doshi JA. Measurement and rates of persistence with and
adherence to biologics. for rheumatoid arthritis: a systematic review. Clin
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