NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. announced today that the United States Food and Drug
Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 1
to recommend approval of the proposed dose of tofacitinib for the
treatment of adult patients with active psoriatic arthritis (PsA).
Pfizer submitted supplemental new drug applications (sNDAs) for XELJANZ®
5 mg twice daily (BID) and XELJANZ® XR extended release 11 mg
once daily (QD) for this pending indication. The role of the Advisory
Committee is to provide recommendations to the FDA. The FDA decision on
whether to approve tofacitinib for PsA is anticipated by December 2017.
“Today marks an important positive step in our journey to potentially
bring tofacitinib to adult patients living with active psoriatic
arthritis and we are pleased with the Committee’s positive
recommendation based on the favorable benefit:risk profile for
tofacitinib,” said Michael Corbo, Chief Development Officer,
Inflammation & Immunology, Pfizer Global Product Development. “If
approved, tofacitinib would be the first Janus kinase (JAK) inhibitor
for psoriatic arthritis. We look forward to working with the FDA to
complete review of the applications.”
The AAC discussions were based on Pfizer’s applications for tofacitinib
in PsA, which are currently under review by the FDA. These include data
from the tofacitinib Phase 3 trials in PsA, as well as additional safety
analyses from the broader tofacitinib clinical development program.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, autoimmune, inflammatory disease
that includes manifestations in peripheral joints, tendons, ligaments,
bone and skin. PsA may include a variety of symptoms such as joint pain
and stiffness, swollen toes and fingers, persistent painful tendonitis,
irreversible joint damage and reduced range of motion. The disease
usually appears between the ages of 30 to 50, equally between men and
women, and can limit daily activities.
About Tofacitinib Citrate
Tofacitinib citrate is a Janus kinase (JAK) inhibitor. It is not
currently approved for the treatment of PsA.
As the developer of tofacitinib, Pfizer is committed to advancing the
science of JAK inhibition and enhancing understanding of tofacitinib
through robust clinical development programs in the treatment of
immune-mediated inflammatory conditions.
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. In rheumatoid arthritis, 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.
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It is not known if XELJANZ/XELJANZ XR is safe and effective in people
with hepatitis B or C.
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XELJANZ/XELJANZ XR is not for people with severe liver problems.
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It is not known if XELJANZ/XELJANZ XR is safe and effective in
children.
Important Safety Information
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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.
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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.
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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.
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Viral reactivation, including cases of herpes virus reactivation
(e.g., herpes zoster), was observed in clinical studies with XELJANZ.
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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.
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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).
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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. 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 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.
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Some people taking XELJANZ have had 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.
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Use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment
is not recommended.
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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.
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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/XELJANZ XR or
breastfeed. They should not do both.
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In carriers of the hepatitis B or C virus (viruses that affect the
liver), the virus may become active while using XELJANZ/XELJANZ XR.
Healthcare providers may do blood tests before and during treatment
with XELJANZ/XELJANZ XR.
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Common side effects of XELJANZ/XELJANZ XR 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/XELJANZ XR, including BOXED WARNING and Medication Guide: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.
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
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DISCLOSURE NOTICE: The information contained in this release is as of
August 3, 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 a potential
new indication for XELJANZ and XELJANZ XR for the treatment of adult
patients with active psoriatic arthritis (the “potential indication”),
including its 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 the potential indication or any other potential
indications for XELJANZ or XELJANZ XR may be filed with regulatory
authorities in any jurisdictions; whether and when the FDA may approve
the supplemental new drug applications for XELJANZ and XELJANZ XR for
the potential indication and whether and when regulatory authorities in
any jurisdictions may approve any other applications that may be filed
or pending 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, including the potential indication; 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170803006164/en/
Source: Pfizer Inc.