Pfizer China announced today that it has received approval from
the Chinese Food and Drug Administration (CFDA) to market its oral
Janus kinase (JAK) inhibitor, XELJANZ® (tofacitinib citrate), in
China for the treatment of adult patients with moderately to
severely active rheumatoid arthritis (RA) who have had an
inadequate response or intolerance to methotrexate (MTX). It may be
used in combination with MTX or other non-biologic
disease-modifying antirheumatic drugs (DMARDs).
XELJANZ® is the first JAK inhibitor approved for RA patients.
JAK inhibitors act on the JAK pathway by working inside the cell to
disrupt a signaling pathway believed to play a role in the
inflammation associated with moderately to severely active RA.
“The introduction of the first oral JAK inhibitor for RA in
China, XELJANZ®, builds upon Pfizer’s legacy as an innovator in
inflammation and immunology and provides a new option for
physicians and adult patients with moderately to severely active RA
who may prefer an oral treatment for this chronic condition,” said
Mr. Guohong Shan, China Country Lead, Pfizer Innovative Health.
"We applaud the efforts of Chinese Government and the CFDA to
bring new medicines to the Chinese healthcare system. Pfizer is
committed to working closely with the CFDA, and will continue to
partner with the Chinese government with the goal to help improve
the lives of patients and people in China,” said Dr. Wu Xiaobin,
Country Manager of Pfizer China.
The CFDA approval is based upon the efficacy and safety data
from global RA pivotal study A3921046 China sub group,
pharmacokinetics data from China PK study A3921065 and sufficient
data from global RA pivotal studies including five phase III
studies and a long-term extension study. The recommended dose of
XELJANZ approved in China is 5 mg taken twice daily, orally with or
without food.
About XELJANZ
XELJANZ® (tofacitinib citrate) has been approved for use in over
50 countries.i Since XELJANZ was first approved in the U.S. in
2012, it has been prescribed to more than 90,000 patients
worldwide.ii
In January 2017, the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) adopted a
positive opinion recommending XELJANZ 5 mg twice daily (BID) for
the treatment of patients with moderate to severe active RA. The
CHMP’s opinion is now with the European Commission for final
decision. In the European Union, XELJANZ is an investigational
medicine and has not been approved for use.
Tofacitinib is included in a number of RA treatment
recommendations, including those published by the Asia Pacific
League of Associations for Rheumatology (APLAR), European League
Against Rheumatism (EULAR) and the American College of Rheumatology
(ACR).
Pfizer is committed to advancing the science of JAK inhibition
and enhancing understanding of XELJANZ through robust clinical
development programs in the treatment of immune-mediated
inflammatory conditions.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune
disease that causes a range of symptoms, including pain and
swelling in the joints,iii iv particularly those in the hands, feet
and knees.iv Although the exact cause of RA is unknown,iv 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.vi Some people are at increased risk of developing
RA, including people with a family history of RA, smokers and
women.v Three times as many women are affected by RA compared to
men.vi RA affects approximately 23.7 million people worldwide and 4
million people in China.vi It can develop at any time during
adulthood, but it usually occurs between 40 and 70 years of age.vi
According to 28 joint disease activity score (DAS28) criteria, a
national multi-center cross-sectional survey showed that the rate
of remission in patients with RA in China was 8.6% and the
disability rate is about 50.3%.vi There is a large gap between the
RA remission rate in China and western countries.
XELJANZ/XELJANZ XR U.S. Label Information
XELJANZ (tofacitinib citrate)/XELJANZ XR (tofacitinib citrate)
extended-release is a prescription medicine called a Janus kinase
(JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults with
moderately to severely active rheumatoid arthritis in which
methotrexate did not work well. XELJANZ/XELJANZ XR may be used as a
single agent or in combination with methotrexate (MTX) or other
non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of
XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent
immunosuppressants, such as azathioprine and cyclosporine, is not
recommended.
- It is not known if XELJANZ/XELJANZ XR
is safe and effective in people with hepatitis B or C.
- XELJANZ/XELJANZ XR is not for people
with severe liver problems.
- It is not known if XELJANZ/XELJANZ XR
is safe and effective in children.
Important Safety Information
- XELJANZ/XELJANZ XR can lower the
ability of the immune system to fight infections. Some people can
have serious infections while taking XELJANZ/XELJANZ XR, 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/XELJANZ XR, and monitor them closely
for signs and symptoms of TB and other infections during treatment.
People should not start taking XELJANZ/XELJANZ XR 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/XELJANZ XR may increase the
risk of certain cancers by changing the way the immune system
works. Lymphoma and other cancers, including skin cancers, can
happen in patients taking XELJANZ/XELJANZ XR.
- The risks and benefits of treatment
should be considered prior to initiating XELJANZ/XELJANZ XR 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/XELJANZ XR. Update immunizations in
agreement with current immunization guidelines prior to initiating
XELJANZ/XELJANZ XR 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/XELJANZ XR
can get tears in their stomach or intestines. This happens most
often in people who also take nonsteroidal anti-inflammatory drugs
(NSAIDs), corticosteroids, or methotrexate.
- XELJANZ/XELJANZ XR should be used with
caution in patients who may be at increased risk for
gastrointestinal perforation (e.g., patients with a history of
diverticulitis), or who have a narrowing within their digestive
tract. 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/XELJANZ XR 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/XELJANZ XR and while they are taking XELJANZ/XELJANZ XR,
to check for these side effects. Normal cholesterol levels are
important to good heart health. Healthcare providers may stop
XELJANZ/XELJANZ XR treatment because of changes in blood cell
counts or liver test results.
- Use of XELJANZ/XELJANZ XR 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/XELJANZ XR will harm an unborn baby.
To monitor the outcomes of pregnant women exposed to
XELJANZ/XELJANZ XR, 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.
Please click the direct link to the full US Prescribing
Information for XELJANZ/XELJANZ XR, including Boxed Warning and
Medication Guide:
http://labeling.pfizer.com/ShowLabeling.aspx?id=959.
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, we have worked to make a difference for
all who rely on us. We routinely post information that may be
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DISCLOSURE NOTICE: The information contained in this
release is as of March 15, 2017. 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
and XELJANZ XR, and an approval for XELJANZ in China for the
treatment of adult patients with moderately to severely active RA
who have had an inadequate response or intolerance to methotrexate,
including their potential benefits, 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,
without limitation, the ability to meet anticipated trial
commencement and completion dates and regulatory submission dates,
as well as the possibility of unfavorable clinical trial results,
including unfavorable new clinical data and additional analyses of
existing clinical data; uncertainties regarding the commercial
success of XELJANZ and XELJANZ XR; whether and when any other
applications for XELJANZ or XELJANZ XR may be filed with regulatory
authorities in any jurisdictions; whether and when regulatory
authorities in any jurisdictions may approve any such applications
and/or any other applications that are pending (including the
marketing authorization application currently under review by the
European Medicines Agency for the treatment of moderate to severe
active RA) or may be filed for XELJANZ or XELJANZ XR, 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 XELJANZ XR; 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, 2016 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 U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
______________________
i Pfizer Data on File. XELJANZ Worldwide Registration Status
2016.ii Pfizer Data on File. XELJANZ Patient Experience Jan 26.iii
Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001;
358:903-911.iv Medline Plus, “Rheumatoid Arthritis” Accessed 11
October 2015. Available at
http://www.nlm.nih.gov/medlineplus/ency/article/000431.htm.v Mayo
Clinic, “Rheumatoid Arthritis.” Accessed 14 September 2015.
Available at
http://www.mayoclinic.com/health/rheumatoid-arthritis/DS00020/DSECTION=risk-factors.vi
Li ZG, Nat Rev Rheumatol. 2015 May;11(5):313-7
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For PfizerLoucineh Mardirossian, +61 472 812
771loucineh.mardirossian@pfizer.com
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