Pfizer Inc. announced today that the United States Food and Drug
Administration (FDA) accepted for review Pfizer’s new drug
application (NDA) for XELJANZ® (tofacitinib citrate) 11 mg once
daily modified release tablets for the treatment of moderate to
severe rheumatoid arthritis (RA) in patients who have had an
inadequate response or intolerance to methotrexate (MTX). The FDA
has provided an anticipated Prescription Drug User Fee Act (PDUFA)
action date in February 2016 for the NDA.
The NDA for XELJANZ 11 mg once daily modified release is based
on data from a clinical pharmacology program designed to
demonstrate equivalence in key pharmacokinetic parameters to
XELJANZ 5 mg twice daily.
“This filing underscores our commitment to helping advance
patient care and our goal of providing innovative solutions for
patients with RA,” said Rory O’Connor, MD, senior vice president
and head of Global Medical Affairs, Global Innovative
Pharmaceuticals Business, Pfizer Inc. “If approved, it would bring
us one step closer to offering the first and only once-daily oral
Janus kinase inhibitor treatment for those living with moderate to
severe RA who have had an inadequate response or intolerance to
methotrexate.”
As the developer of XELJANZ, Pfizer is a leader in the research
of this new class of medications. XELJANZ is approved in 40
countries around the world for the treatment of moderate to severe
rheumatoid arthritis (RA). In the United States, XELJANZ has a
boxed warning for serious infections and malignancies.
About the XELJANZ Clinical Development Program
Pfizer is committed to building on the science and understanding
of JAK inhibition and XELJANZ through a robust clinical development
program in a range of immune-mediated inflammatory conditions in
the areas of rheumatology, dermatology and gastroenterology. A
supplemental new drug application for XELJANZ 10 mg and 5 mg
tablets twice daily is currently under review with the FDA for the
treatment of adult patients with moderate to severe chronic plaque
psoriasis who are candidates for systemic therapy or phototherapy.
The benefit:risk profile of XELJANZ in RA has been studied in
approximately 6,200 patients in the global clinical development
program for XELJANZ in moderate to severe RA.
XELJANZ U.S. Label Information
XELJANZ is a prescription medicine called a Janus kinase (JAK)
inhibitor. The recommended dose is 5 mg twice-daily (BID). XELJANZ
is used to treat adults with moderately to severely active
rheumatoid arthritis in which methotrexate did not work well.
XELJANZ may be used as a single agent or in combination with MTX or
other non-biologic disease-modifying antirheumatic drugs (DMARDs).
Use of XELJANZ in combination with biologic DMARDs or potent
immunosuppressants, such as azathioprine and cyclosporine is not
recommended.
- 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.
People may be at a higher risk of developing
shingles.
- XELJANZ may increase the risk of
certain cancers by changing the way the immune system works.
Lymphoma and other cancers, including skin cancers, have happened
in patients taking XELJANZ.
- The risks and benefits of treatment
should be considered prior to initiating XELJANZ in patients with
chronic or recurrent infection; who have been exposed to
tuberculosis; with a history of a serious or an opportunistic
infection; who have resided or traveled in areas of endemic
tuberculosis or endemic mycoses; or with underlying conditions that
may predispose them to infection.
- Viral reactivation, including cases of
herpes virus reactivation (e.g., herpes zoster), was observed in
clinical studies with XELJANZ.
- Use of live vaccines should be avoided
concurrently with XELJANZ. Update immunizations in agreement with
current immunization guidelines prior to initiating XELJANZ
therapy.
- Some people who have taken XELJANZ with
certain other medicines to prevent kidney transplant rejection have
had a problem with certain white blood cells growing out of control
(Epstein Barr virus-associated post-transplant lymphoproliferative
disorder).
- Some people taking XELJANZ get tears in
their stomach or intestines. This happens most often in people who
also take nonsteroidal anti-inflammatory drugs (NSAIDs),
corticosteroids, or methotrexate. 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 habits. XELJANZ
should be used with caution in patients who may be at increased
risk for gastrointestinal perforation (e.g., patients with a
history of diverticulitis).
- 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.
- Use of XELJANZ in patients with severe
hepatic impairment is not recommended.
- 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 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).
Please click the direct link to the full prescribing information
for XELJANZ, including boxed warning and Medication Guide:
http://labeling.pfizer.com/ShowLabeling.aspx?id=959.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune
disease that causes a range of symptoms, including stiffness and
swelling in the joints,1,2 particularly those in the hands, feet
and knees.3 Although the exact cause of RA is unknown,1 it is
considered to be an autoimmune disease, because the immune system
in people with RA mistakes the body’s healthy tissues for a threat
and attacks them.3 Some people are at increased risk of developing
RA, including people with a family history of RA, smokers and
women.3 Three times as many women are affected by RA compared to
men.2 RA affects approximately 23.7 million people4 worldwide and
1.6 million people in the United States.5,6 It can develop at any
time during adulthood, but it usually occurs between 40 and 70
years of age.2
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.
DISCLOSURE NOTICE: The information contained in this
release is as of July 2, 2015. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the
result of new information or future events or developments.
This release contains forward-looking information about XELJANZ,
including its potential benefits and a potential once daily
formulation of XELJANZ that involves substantial risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties
inherent in research and development, including the possibility of
unfavorable clinical trial results, including unfavorable new
clinical data and additional analyses of existing clinical data;
whether and when any applications for XELJANZ may be filed with
regulatory authorities in any other jurisdictions; whether and when
the FDA may approve the NDA or the supplemental new drug
application and whether and when regulatory authorities in other
jurisdictions in which such applications are pending or will be
submitted may approve such applications, which will depend on the
assessment by such regulatory authorities of the benefit-risk
profile suggested by the totality of the efficacy and safety
information submitted; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of XELJANZ; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2014 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the SEC and available
at www.sec.gov and www.pfizer.com.
1 Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001;
358:903-911.
2 Medline Plus, “Rheumatoid Arthritis” Accessed 11 October 2011.
Available at
http://www.nlm.nih.gov/medlineplus/ency/article/000431.htm.
3 Mayo Clinic, “Rheumatoid Arthritis.” Accessed 14 September
2011. Available at
http://www.mayoclinic.com/health/rheumatoid-arthritis/DS00020/DSECTION=risk-factors.
4 World Health Organization, “The Global Burden of Disease, 2004
Update.” Accessed 13 March 2012. Available at
http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.
5 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.
6 Howden, L., Meyer, J., 2010 U.S. Census Bureau results ---
U.S. Census Bureau, 2010 Census Summary File 1.
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Pfizer Inc.Media:Steven Danehy, +1
978-273-3946Steven.Danehy@pfizer.comorInvestors:Chuck Triano, +1
212-733-3901Charles.E.Triano@pfizer.com
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