Pfizer Inc. (NYSE:PFE) announced today top-line results from
Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE)
Sustain, the third Phase 3 study of XELJANZ® (tofacitinib citrate)
being investigated in patients with moderately to severely active
ulcerative colitis (UC). OCTAVE Sustain is a 52 week study that
evaluated oral tofacitinib 5 mg and 10 mg twice daily (BID) as a
maintenance treatment in adult patients with moderately to severely
active UC who previously completed and achieved clinical response
in either the OCTAVE Induction 1 or OCTAVE Induction 2 studies.
Top-line results from the OCTAVE Sustain study showed that the
proportion of patients in remission at week 52, the primary
efficacy endpoint, was significantly greater in both the
tofacitinib 5 and 10 mg BID groups compared to placebo. In OCTAVE
Sustain, remission was defined as total Mayo scorea ≤2, no subscore
>1, and rectal bleeding subscore of 0. No new or unexpected
safety findings for tofacitinib were observed in the study.
“Ulcerative colitis is a chronic, often debilitating
inflammatory condition that can be difficult to treat. There are a
limited number of therapies available and patients need additional
treatment options” said Michael Corbo, PhD, Chief Development
Officer, Inflammation & Immunology, Pfizer, Inc. “These
findings, along with the previously released positive induction
data from the OCTAVE studies, are encouraging and provide evidence
that tofacitinib, if approved, has the potential to be an effective
new oral treatment option that both induces and maintains
remission. We are proud to advance our clinical development program
for tofacitinib as we work to bring a potential new treatment
option to patients living with ulcerative colitis.”
OCTAVE Sustain is a Phase 3, randomized, double-blind,
placebo-controlled, parallel group, multi-center study. A total of
593 patients were randomized to tofacitinib 5 mg BID, tofacitinib
10 mg BID and placebo BID. Detailed analyses of OCTAVE Sustain,
including additional efficacy and safety data, will be submitted
for presentation at a future scientific meeting.
About the OCTAVE Clinical Development Program
The OCTAVE global clinical development program includes three
Phase 3 studies, OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE
Sustain, as well as a long-term extension trial, OCTAVE Open. We
expect that these four studies will form the submission package to
regulatory authorities for a potential UC indication.
OCTAVE Induction 1 and OCTAVE Induction 2 are two replicate
Phase 3 placebo-controlled studies that evaluated induction of
remission by oral tofacitinib 10 mg BID in adult patients with
moderately to severely active UC. Subjects needed to have failed or
been intolerant to UC treatments including corticosteroids,
thiopurines or tumor necrosis factor inhibitors (TNFi).
OCTAVE Sustain is a Phase 3 placebo-controlled study evaluating
oral tofacitinib 5 mg and 10 mg BID as maintenance therapy in adult
patients with moderately to severely active UC.
OCTAVE Open is an ongoing open-label extension study designed to
assess the safety and tolerability of tofacitinib 5 mg and 10 mg
BID in patients who have completed or who have had treatment
failure in OCTAVE Sustain or who were non-responders upon
completing OCTAVE Induction 1 or 2.
About Ulcerative Colitis
UC is a chronic, often debilitating inflammatory bowel disease
that affects millions of people worldwide. It is believed that UC
is the result of complex interactions between multiple factors that
include the environment, genetic predisposition, immune response,
and the gut microbiome in the colon or intestines. It can cause
abdominal pain, fever, weight loss and chronic, bloody diarrhea. UC
can have an effect on work, family and social activities. In up to
one-third of patients with UC, treatment is not completely
successful or complications arise. Under these circumstances,
surgery to remove the colon (colectomy) may be considered. Even
after surgery, certain symptoms of UC may still persist.
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. In the United
States, XELJANZ XR 11 mg QD is the first and only once-daily oral
JAK inhibitor approved for the treatment of moderate to severe
rheumatoid arthritis (RA).
As the developer of XELJANZ/XELJANZ XR, Pfizer is a leader in
JAK innovation. XELJANZ is approved in more than 45 countries
around the world for the treatment of moderate to severe RA as a
second-line therapy after failure of one or more disease-modifying
antirheumatic drugs (DMARDs).
Pfizer is committed to advancing the science of JAK inhibition
and enhancing understanding of XELJANZ through a robust clinical
development program. The efficacy and safety profile of XELJANZ has
been studied in approximately 6,200 patients with moderate to
severe RA, amounting to more than 19,400 patient-years of drug
exposure in the global clinical development program.
References available upon request
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®
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 best-known consumer healthcare
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. For more information, please visit us
at www.pfizer.com. In addition, to learn more, follow us on
Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this
release is as of July 28, 2016. 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 regulatory authorities in any
jurisdictions may approve 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, 2015 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.
a Mayo score is a measurement index comprised of four categories
(stool frequency, rectal bleeding, findings on endoscopy, physician
global assessment) that are each rated from 0 (normal) to 3 (most
severe) for a total score that ranges from 0-12.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160728006530/en/
PfizerMedia:Steven Danehy,
978-273-3946Steven.Danehy@pfizer.comorInvestors:Chuck Triano,
212-733-3901Charles.E.Triano@pfizer.com
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