Pfizer Announces U.S. FDA Filing Acceptance of Supplemental New Drug Application for XELJANZ® (tofacitinib citrate) for the Treatment of Adult Patients with Active Psoriatic Arthritis

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. announced today that the United States Food and Drug
Administration (FDA) has accepted for review the supplemental New Drug
Application (sNDA) for XELJANZ^® (tofacitinib citrate) 5 mg
twice daily (BID) for the treatment of adult patients with active
psoriatic arthritis (PsA). A separate sNDA was also accepted for XELJANZ
XR^® (tofacitinib citrate) extended release 11 mg once daily
use in PsA. The sNDA submission is based on data from the Phase 3 Oral
Psoriatic Arthritis TriaLs (OPAL) clinical
development program, which consisted of two pivotal trials and a
long-term extension study, evaluating the safety and efficacy of XELJANZ
in patients with active PsA who had failed prior PsA treatments. The FDA
has provided an anticipated Prescription Drug User Fee Act (PDUFA)
action date in December 2017 for the sNDAs.

“Psoriatic arthritis is a complex disease involving joint inflammation
and damage, psoriasis, and musculoskeletal inflammation, which may limit
physical functioning for people living with the disease. Despite
advances in the treatment of psoriatic arthritis in recent years, many
people are still living with active disease and are in need of
additional therapeutic options,” said Michael Corbo, Chief Development
Officer, Inflammation & Immunology, Global Product Development. “We
believe that XELJANZ has the potential to provide patients with
psoriatic arthritis and their physicians a new treatment option that
also offers oral administration. If approved, XELJANZ or once-daily
XELJANZ XR would be the first and only Janus kinase inhibitor for the
treatment of this chronic inflammatory disease.”

Two pivotal Phase 3 studies were included in the submission package.
OPAL Broaden was conducted in conventional synthetic disease-modifying
antirheumatic drug (csDMARD) inadequate response (IR) and tumor necrosis
factor inhibitor (TNFi)-naïve patient populations. The study included an
active control arm of adalimumab. However, the study was not designed
for non-inferiority or superiority comparisons between adalimumab and
XELJANZ. OPAL Beyond was conducted in TNFi-IR patients and was the first
PsA study focused exclusively in this population. Both studies met their
primary efficacy endpoints showing a statistically significant
improvement with XELJANZ 5 mg and 10 mg BID compared to treatment with
placebo at three months as measured by American College of Rheumatology
20 (ACR20) response and change from baseline in Health Assessment
Questionnaire Disability Index (HAQ-DI) score. In both studies adverse
events were more frequent with XELJANZ 5 mg and 10 mg BID versus
placebo. Overall safety findings were consistent with those observed in
the broader rheumatology clinical development program for XELJANZ.
Interim results from OPAL Balance, the long-term extension study of
XELJANZ in patients with active PsA, were also included in the
submission package.

About Psoriatic Arthritis

Psoriatic Arthritis (PsA) is a chronic inflammatory multisystem disease.
PsA can cause joint pain and stiffness, skin and nail psoriasis, swollen
toes and fingers, persistent painful tendonitis, and irreversible joint
damage. There are an estimated three million people in the U.S. and
Europe combined with active PsA. Real world disease prevalence may be
even higher because it is often misdiagnosed or goes undiagnosed
altogether.

About XELJANZ (tofacitinib citrate) and XELJANZ XR (tofacitinib
citrate) extended-release

XELJANZ^®/XELJANZ XR^® (tofacitinib citrate) is a
prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ is
not currently approved for the treatment of PsA.

As the developer of XELJANZ/XELJANZ XR, Pfizer is a leader in JAK
innovation. The XELJANZ RA development program includes more than eight
years of safety data from the long-term extension studies representing
over 21,100 patient-years of drug exposure to date.

XELJANZ is approved in more than 80 countries around the world for the
treatment of moderately to severely active rheumatoid arthritis (RA). In
the United States, Argentina, and Macau, XELJANZ XR is the first
once-daily oral JAK inhibitor approved for the treatment of moderately
to severely active RA.

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.

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.

• 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.

• 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.
• 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/XELJANZ XR, including boxed warning and Medication Guide: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.

Pfizer Inc.: Working together for a healthier world^®

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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
May 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
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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