Black triangle indicating additional safety
monitoring requirement for CHAMPIX in the EU has been removed
Pfizer Inc. (NYSE:PFE) today announced that the European Summary
of Product Characteristics (SmPC) and Package Leaflet for CHAMPIX®
(varenicline) have been updated to include safety and efficacy data
from the EAGLES (Evaluating Adverse Events in a
Global Smoking Cessation Study) trial.1
As part of the update, the black triangle symbol, which indicated
that additional safety monitoring for CHAMPIX in the EU was
required, has been removed. EAGLES is a post-authorization safety
study/post-marketing requirement study, which was conducted in 16
countries and designed to evaluate the neuropsychiatric safety of
CHANTIX/CHAMPIX and bupropion versus placebo and nicotine
replacement therapy patch (NRT) in patients with and without a
history of psychiatric disorder. The outcomes of the EAGLES trial
were recently published in The Lancet.2 The CHAMPIX EU label update
was implemented following the adoption of a positive opinion by the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency.
“Smoking remains a major public health challenge, causing more
than 5 million deaths worldwide each year,” said Rory O’Connor, MD,
Chief Medical Officer, Internal Medicine, Pfizer Inc. “Since its
introduction in the EU nearly 10 years ago, CHAMPIX has been
prescribed to millions of adults to help them stop smoking. The new
safety and efficacy information in the European label further
supports the importance of CHAMPIX as a treatment option for
healthcare providers and for those who are trying to quit
smoking.”
The EAGLES trial is a large randomized, double-blind, active and
placebo-controlled study that was conducted by Pfizer in
collaboration with GlaxoSmithKline at the request of, and designed
in consultation with, the U.S. Food and Drug Administration (FDA)
and the European Medicines Agency. The primary safety endpoint was
a composite of neuropsychiatric adverse events that have been
reported in the post-marketing experience for CHANTIX/CHAMPIX. The
study also included an efficacy objective to determine smoking
abstinence rates in patients treated with CHAMPIX or bupropion,
relative to placebo, during the last four weeks of treatment.
The European Medicines Agency approval to update the CHAMPIX
label applies to all 28 EU member states, plus Iceland, Norway and
Liechtenstein. The EAGLES data are currently under review by other
regulatory authorities worldwide.
The CHANTIX/CHAMPIX labeling globally includes a boxed
warning/warning regarding serious neuropsychiatric adverse events
that have been reported in some patients attempting to quit smoking
while taking CHANTIX/CHAMPIX in the post-marketing experience. Some
people have had changes in behavior, hostility, agitation,
depressed mood, and suicidal thoughts or actions while using
CHANTIX/CHAMPIX to help them quit smoking. If the CHANTIX/CHAMPIX
patient, their family or caregiver notices any of these symptoms or
behaviors, they should stop taking CHANTIX/CHAMPIX and call their
doctor right away. They should tell their doctor about any history
of depression or other mental health problems, which could get
worse while taking CHANTIX/CHAMPIX.
About CHANTIX®
CHANTIX® (also known as CHAMPIX® in the EU and other countries)
was approved by the FDA in May 2006 as a prescription medication
that, along with support, helps adults 18 and over stop smoking.
Adults who smoke may benefit from quit-smoking support programs
and/or counseling during their quit attempt. It’s possible that
patients might slip up and smoke while taking CHANTIX/CHAMPIX. If
patients slip up, they can stay on CHANTIX/CHAMPIX and keep trying
to quit.
Important CHANTIX (varenicline) Safety Information
Some people have had changes in behavior, hostility,
agitation, depressed mood, suicidal thoughts or actions while using
CHANTIX to help them quit smoking. Some people had these symptoms
when they began taking CHANTIX, and others developed them after
several weeks of treatment or after stopping CHANTIX. If the
CHANTIX patient, their family or caregiver notice any of these
symptoms or behaviors, they should stop taking CHANTIX and call
their doctor right away. They should tell their doctor about any
history of depression or other mental health problems, which could
get worse while taking CHANTIX.
Some people had seizures during treatment with CHANTIX. Most
cases happened during the first month of treatment. Patients should
tell their doctor if they have a history of seizures. If a patient
has a seizure during treatment with CHANTIX, he/she should stop
taking CHANTIX and contact his/her healthcare provider right
away.
Patients should decrease the amount of alcohol they drink while
taking CHANTIX until they know if CHANTIX affects their ability to
tolerate alcohol. Some people experienced increased drunkenness,
unusual or sometimes aggressive behavior, or memory loss of events
while consuming alcohol during treatment with CHANTIX.
Patients should not take CHANTIX if they’ve had a serious
allergic or skin reaction to it. If they develop serious allergic
or skin reactions, including swelling of the face, mouth, throat,
or a rash, they should stop taking CHANTIX and see their doctor
right away as some of these can be life-threatening.
Patients should tell their doctor if they have a history of
heart or blood vessel problems or have any new or worse symptoms
during treatment with CHANTIX. Patients should get emergency
medical help right away if they have any symptoms of a heart attack
or stroke.
Dosing may be different for patients who have kidney problems.
Until the patient knows how CHANTIX affects them, they should use
caution when driving or operation machinery. Common side effects
include nausea, trouble sleeping and unusual dreams. CHANTIX should
not be taken with other quit-smoking products. Patients should tell
their doctor which medicines they are taking as these medicines may
work differently when quitting smoking.
Click here for Full Prescribing Information, including BOXED
WARNING and Medication Guide.
About 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, 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 May 23, 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 regarding
CHANTIX/CHAMPIX, 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,
uncertainties regarding the commercial impact of the results of the
EAGLES study; uncertainties regarding the impact of the EAGLES
study on the product labeling for CHANTIX/CHAMPIX in the United
States or other jurisdictions outside the European Union; the risk
that clinical trial data are subject to differing interpretations,
including by regulatory authorities; the uncertainties inherent in
research and development; 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.
# # # # #
References:
1 Champix® (varenicline): EU Summary of Product Characteristics.
Pfizer; May 2016.
2 Anthenelli RM, Benowitz NL, West R, et al. Neuropsychiatric
safety and efficacy of varenicline, bupropion, and nicotine patch
in smokers with and without psychiatric disorders (EAGLES): a
double-blind, randomized, placebo-controlled clinical trial.
Lancet. 2016 Apr 19:e1-e14.[Epub ahead of print].
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version on businesswire.com: http://www.businesswire.com/news/home/20160523005659/en/
Pfizer Inc.Media:Steven Danehy,
212-733-1538Steven.Danehy@pfizer.comorInvestorsCharles Triano,
212-733-3901Charles.E.Triano@pfizer.com
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