NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. announced today that the supplemental New Drug Application
(sNDA) for XELJANZ® (tofacitinib citrate), an investigational
oral treatment for adult patients with moderately to severely active
ulcerative colitis (UC), has been accepted for filing by the U.S. Food
and Drug Administration (FDA).
The FDA has provided an anticipated Prescription Drug User Fee Act
(PDUFA) action date in March 2018 for the sNDA.
“Ulcerative colitis is a debilitating inflammatory disease that impacts
the physical, emotional and social well-being of nearly one million
people in the United States, many of whom are not able to manage their
disease,” said Michael Corbo, Chief Development Officer, Inflammation &
Immunology, Global Product Development, Pfizer Inc. “We look forward to
working with the FDA as they consider the application for tofacitinib in
UC, with the goal of offering, if approved, the first oral Janus kinase
(JAK) inhibitor as a therapeutic option for people living with
moderately to severely active UC.”
The sNDA submission package included data from three pivotal Phase 3
studies from the Oral Clinical
Trials for tofAcitinib
in ulceratiVE colitis global
clinical development program (OCTAVE Induction 1, OCTAVE Induction 2 and
OCTAVE Sustain) evaluating the safety and efficacy of tofacitinib in
patients with moderately to severely active UC, and OCTAVE Open, the
open label long-term extension study of tofacitinib in patients who
completed or who had treatment failure in OCTAVE Sustain, or who were
non-responders in OCTAVE Induction 1 or 2. Full results from
OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain were published
in The New England Journal of Medicine in May 2017.
About Ulcerative Colitis
UC is a chronic, debilitating and often misunderstood inflammatory bowel
disease that affects millions of people worldwide. Symptoms
of UC can include chronic diarrhea with blood and mucus, abdominal pain
and cramping, fever and weight loss. While the exact cause of UC is
unknown, it is believed to be the result of complex interactions between
multiple factors that include genetic predisposition and an exaggerated
immune response to a microbial trigger. UC can have a significant effect
on work, family and social activities. Despite receiving treatment, half
of patients continue to experience symptoms. Under these circumstances,
surgery to remove the colon (colectomy), may be considered for some
patients.
About Tofacitinib Citrate
Tofacitinib citrate is a Janus kinase (JAK) inhibitor. It is not
currently approved for the treatment of UC.
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.
-
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.
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 healthcare products. Our global portfolio
includes medicines and vaccines as well as many of the world's
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DISCLOSURE NOTICE: The information contained in this release is as of
July 13, 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 for the treatment of adult patients with
moderately to severely active UC (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 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 applications for the potential
indication may be filed with regulatory authorities in any
jurisdictions; whether and when the FDA will approve the sNDA for the
potential indication and whether and when regulatory authorities in any
jurisdictions may approve any such applications and/or any other
applications that are pending 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, 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.
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Source: Pfizer Inc.