Eliquis® (apixaban) Clinical
Data Include Results from a Phase 4 Trial – EMANATE – to be
Featured in Late-Breaking Science Sessions
Analyses from the ACROPOLIS™ Global
Real-World Data Program Provide Insight into the Anticoagulation of
a Broad Range of NVAF Patients at Risk for Stroke
Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc.
(NYSE:PFE) today announced that 15 abstracts have been accepted for
presentation at the ESC Congress 2017, organized by the European
Society of Cardiology, on August 26-30 in Barcelona, Spain.
Investigational data from the EMANATE
[Eliquis evaluated in acute cardioversion
coMpared to usuAl treatmeNts
for AnTicoagulation in subjEcts with
non-valvular atrial fibrillation (NVAF)] clinical trial will be
presented during the Late-Breaking Science hot line session and
official ESC press conference. EMANATE is a Phase 4 clinical trial
exploring Eliquis® (apixaban) versus standard of care (parenteral
heparin and/or oral anticoagulation with a vitamin K antagonist) in
patients with NVAF expected to undergo cardioversion to
re-establish a regular heart rhythm.
In addition, analyses from ACROPOLIS™ (Apixaban
ExperienCe Through Real-WOrld
POpuLatIon Studies) – the real-world
data program which aims to contribute to the growing body of
evidence related to anticoagulation – will be presented at this
year’s ESC Congress. These analyses focus on the use of Eliquis in
routine clinical practice, including in NVAF patient populations
considered at high risk or particularly vulnerable to stroke or
major bleed due to age, risk prediction scores, and other
cardiovascular comorbidities.
“We are proud to share both clinical trial results and
real-world data analyses that continue to support the medical
community in the advancement of patient care and add to the body of
evidence for Eliquis as a treatment for DVT/PE and for reducing the
risk of stroke in NVAF patients,” said Christoph Koenen, M.D., MBA,
VP, Development Lead, Eliquis, Bristol-Myers Squibb. “These data
supplement our pivotal trial results, providing additional insight
into how Eliquis performs in specific clinical settings such as
cardioversion and broad patient populations representing common
clinical practice settings.”
“As physicians evaluate options for reducing stroke risk in
patients with non-valvular atrial fibrillation, they often face
questions about the effectiveness and safety of therapies in
day-to-day practice,” said Rory O’Connor, M.D., Chief Medical
Officer, Pfizer Innovative Health. “Real-world data analyses, such
as the results shared at this year’s ESC Congress, allow us to
better understand the usage of Eliquis and other anticoagulants in
a variety of settings and alongside clinical data, and have the
potential to help healthcare providers make more informed decisions
about their patient’s care.”
Initial findings from a Bristol-Myers Squibb (BMS)- and Pfizer-
commissioned global policy research project conducted by The
Economist Intelligence Unit (EIU), the research analysis division
of The Economist Group, will also be presented at the ESC Congress.
These findings bring attention to the global disparity of stroke
risk reduction policies, and inadequate detection of risk factors
for stroke – including NVAF – in clinical practice. The full
report, which will be released by The EIU on September 21, is part
of the BMS-Pfizer Alliance’s commitment to collaborating with
patient advocacy and research organizations around the world to
uncover barriers to atrial fibrillation screening and appropriate
treatment to reduce the risk of stroke for patients with NVAF.
- Data from the EMANATE trial will be
presented during various sessions on August 28:
- 09:17 – 09:25 CET - Press Conference –
Hot Line: Late-Breaking Clinical Trials 2
- 11:18 – 11:28 CET - Hot Line:
Late-Breaking Clinical Trials 2
- 15:40 – 16:00 CET - Meet the Trialists
- EMANATE
- 15:37 – 18:00 CET - Anticoagulation for
cardioversion of atrial fibrillation: exploring areas of
uncertainty
- One-year follow-up data evaluating the
safety and effectiveness of continued oral anticoagulation
treatment beyond one year after venous thromboembolism (VTE) in
patients at intermediate risk of recurrence will be presented as an
oral presentation on August 26, from 14:24 to 14:42 CET.
- A real-world data analysis
investigating the safety and effectiveness of Eliquis in high-risk
patient subgroups will be featured as part of the Stroke Prevention
poster session on August 28, from 8:30 to 12:30 CET.
- A real-world data analysis evaluating
the safety and effectiveness of Eliquis specifically in NVAF
patients aged 65 years and older will be presented as an oral
presentation during the Anticoagulation in Atrial Fibrillation
Rapid Fire Abstract session on August 29 from 15:12 to 15:21
CET.
- Top-line findings from The EIU report
on stroke risk reduction and screening policies in 12 countries
will be presented as a poster on August 28, from 8:30 to 12:30 CET.
The full report will be released by The EIU on September 21.
Below is a complete list of BMS and Pfizer Alliance
presentations during the ESC Congress. Abstracts can be accessed
through the ESC Congress 2017 Scientific Programme.
Title
Presenting Author/Type Date/Time (CET)
Location/Session Clinical Data INR prior to
bleeding is below 3.0 most of the time in patients with atrial
fibrillation using warfarin
Session: Poster Session 3 – Drug
Treatment
Oliveira Guimaraes et al./ Poster Aug. 27,
14:00-18:00
Poster Area Apixaban vs conventional therapy in
anticoagulation-naive patients with atrial fibrillation undergoing
cardioversion: The EMANATE Trial
Sessions:
Hot Line: Late-Breaking Clinical Trials
2
Meet the Trialists - EMANATE
Ezekowitz et al./
Hot Line
Meet the Trialists
Aug. 28,Hot Line: 11:18-11:28Meet the Trialists: 15:40 –
16:00 Hot Line:
Main Auditorium
Meet the Trialists:
Dali – The Hub
Serial IL-6 levels and risk of death in anticoagulated patients
with atrial fibrillation: Insights from the ARISTOTLE trial
Session: Poster Session 4 – Stroke
Prevention
Aulin et al./
Poster
Aug. 28,
8:30-12:30
Poster Area Clinical outcomes in patients with atrial
fibrillation and echocardiographic risk factors for stroke
anticoagulated with apixaban or warfarin
Session: Poster Session 4 – Stroke
Prevention
Vinereanu et al./ Poster Aug. 28,
8:30-12:30
Poster Area Low apolipoprotein A1 is significantly
associated with decreased risk of cardiovascular events in
anticoagulated patients with atrial fibrillation: Insights from the
ARISTOTLE trial
Session: Poster Session 4 – Atrial
Fibrillation Obesity
Pol et al./
Poster
Aug. 28,
8:30-12:30
Poster Area
A novel biomarker-based risk score to
predict death in patients with atrial fibrillation: Insights from
the ARISTOTLE and RE-LY trials
Session: Stroke risk prediction in atrial
fibrillation
Hijazi et al./
Poster
Aug. 29,
14:54-15:12
Valetta – Village 5
Real-World Data and Other
Analyses
Effectiveness and safety of continued oral
anticoagulation treatment beyond 1 year after venous
thromboembolism in patients at intermediate risk: a nationwide
propensity score weighted-cohort study
Session: After pulmonary embolism:
optimising treatment and follow up
Johnsen et al./Oral Aug. 26,
14:24-14:42
Rabat – Village 7 Real-world comparison of major bleeding
risk associated with direct oral anticoagulants or warfarin in
patients with non-valvular atrial fibrillation: a systematic review
and network meta-analysis
Session: Poster Session 3 – Drug
Treatment
Deitelzweig et al./Poster Aug. 27,
14:00-18:00
Poster Area
Effectiveness and safety of apixaban
versus warfarin among high-risk subgroups of non-valvular atrial
fibrillation patients: a propensity score matched analysis
Session: Poster Session 4 – Stroke
Prevention
Li et al./
Poster
Aug. 28,
8:30-12:30
Poster Area
Predictors of warfarin discontinuation or
switching among non-valvular atrial fibrillation patients
Session: Poster Session 4 – Stroke
Prevention
Luo et al./
Poster
Aug. 28,
8:30-12:30
Poster Area Effectiveness and safety of standard and lower
dose apixaban compared to warfarin in non-valvular atrial
fibrillation patients: a propensity score matched analysis
Session: Poster Session 4 – Stroke
Prevention
Li et al./
Poster
Aug. 28,
8:30-12:30
Poster Area Stroke prevention: From policy to clinical
practice in the U.S. and Europe
Session: Poster Session 4 – Cardiovascular
risk factors in general population
Karnad et al./Poster
Aug. 28,
8:30-12:30
Poster Area A changing landscape: temporal trends in
incidence and characteristics of patients hospitalised with venous
thromboembolism.
Session: Best Posters – Best Posters in
acute pulmonary embolism
Johnsen et al./Poster Aug. 28, 14:00-18:00
Poster Area
Risk of major bleeding among non-valvular
atrial fibrillation patients prescribed apixaban, dabigatran,
rivaroxaban or warfarin in the U.S. Medicare population
Session: Poster Session 5 - Bleeding and
LAA Occlusion
Trocio et al./
Poster
Aug. 28,
14:00-18:00
Poster Area
Comparison of stroke and major bleeding
risk of treatment with apixaban vs. rivaroxaban and dabigatran
among elderly non-valvular atrial fibrillation patients in the
United States
Session: Anticoagulation in Atrial
Fibrillation
Deitelzweig et al./Rapid Fire Abstract Aug. 29,
15:12-15:21
Agora 2
About Eliquis
Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By
inhibiting Factor Xa, a key blood clotting protein, Eliquis
decreases thrombin generation and blood clot formation. Eliquis is
approved for multiple indications in the U.S. based on efficacy and
safety data from multiple Phase 3 clinical trials. Eliquis is a
prescription medicine indicated to reduce the risk of stroke and
systemic embolism in patients with nonvalvular atrial fibrillation
(NVAF); for the prophylaxis of deep vein thrombosis (DVT), which
may lead to pulmonary embolism (PE), in patients who have undergone
hip or knee replacement surgery; for the treatment of DVT and PE;
and to reduce the risk of recurrent DVT and PE, following initial
therapy.
ELIQUIS Important Safety Information
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS
INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL
HEMATOMA (A) Premature discontinuation of any oral
anticoagulant, including ELIQUIS, increases the risk of thrombotic
events. If anticoagulation with ELIQUIS is discontinued for a
reason other than pathological bleeding or completion of a course
of therapy, consider coverage with another anticoagulant.
(B) Epidural or spinal hematomas may
occur in patients treated with ELIQUIS who are receiving neuraxial
anesthesia or undergoing spinal puncture. These hematomas may
result in long-term or permanent paralysis. Consider these risks
when scheduling patients for spinal procedures. Factors that can
increase the risk of developing epidural or spinal hematomas in
these patients include:
• use of indwelling epidural
catheters
• concomitant use of other drugs that
affect hemostasis, such as nonsteroidal anti-inflammatory drugs
(NSAIDs), platelet inhibitors, other anticoagulants
• a history of traumatic or repeated
epidural or spinal punctures
• a history of spinal deformity or
spinal surgery
• optimal timing between the
administration of ELIQUIS and neuraxial procedures is not
known
Monitor patients frequently for signs and symptoms of
neurological impairment. If neurological compromise is noted,
urgent treatment is necessary. Consider the benefits
and risks before neuraxial intervention in patients anticoagulated
or to be anticoagulated.
CONTRAINDICATIONS
- Active pathological bleeding
- Severe hypersensitivity reaction to
ELIQUIS (e.g., anaphylactic reactions)
WARNINGS AND PRECAUTIONS
- Increased Risk of Thrombotic Events
after Premature Discontinuation: Premature discontinuation of
any oral anticoagulant, including ELIQUIS, in the absence of
adequate alternative anticoagulation increases the risk of
thrombotic events. An increased rate of stroke was observed during
the transition from ELIQUIS to warfarin in clinical trials in
atrial fibrillation patients. If ELIQUIS is discontinued for a
reason other than pathological bleeding or completion of a course
of therapy, consider coverage with another anticoagulant.
- Bleeding Risk: ELIQUIS increases
the risk of bleeding and can cause serious, potentially fatal,
bleeding.
- Concomitant use of drugs affecting
hemostasis increases the risk of bleeding, including aspirin and
other antiplatelet agents, other anticoagulants, heparin,
thrombolytic agents, SSRIs, SNRIs, and NSAIDs.
- Advise patients of signs and symptoms
of blood loss and to report them immediately or go to an emergency
room. Discontinue ELIQUIS in patients with active pathological
hemorrhage.
- There is no established way to reverse
the anticoagulant effect of apixaban, which can be expected to
persist for at least 24 hours after the last dose (i.e., about two
half-lives). A specific antidote for ELIQUIS is not available.
- Spinal/Epidural Anesthesia or
Puncture: Patients treated with ELIQUIS undergoing
spinal/epidural anesthesia or puncture may develop an epidural or
spinal hematoma which can result in long-term or permanent
paralysis.The risk of these events may be increased by the
postoperative use of indwelling epidural catheters or the
concomitant use of medicinal products affecting hemostasis.
Indwelling epidural or intrathecal catheters should not be removed
earlier than 24 hours after the last administration of ELIQUIS. The
next dose of ELIQUIS should not be administered earlier than 5
hours after the removal of the catheter. The risk may also be
increased by traumatic or repeated epidural or spinal puncture. If
traumatic puncture occurs, delay the administration of ELIQUIS for
48 hours.Monitor patients frequently and if neurological compromise
is noted, urgent diagnosis and treatment is necessary. Physicians
should consider the potential benefit versus the risk of neuraxial
intervention in ELIQUIS patients.
- Prosthetic Heart Valves: The
safety and efficacy of ELIQUIS have not been studied in patients
with prosthetic heart valves and is not recommended in these
patients.
- Acute PE in Hemodynamically Unstable
Patients or Patients who Require Thrombolysis or Pulmonary
Embolectomy: Initiation of ELIQUIS is not recommended as an
alternative to unfractionated heparin for the initial treatment of
patients with PE who present with hemodynamic instability or who
may receive thrombolysis or pulmonary embolectomy.
ADVERSE REACTIONS
- The most common and most serious
adverse reactions reported with ELIQUIS were related to
bleeding.
TEMPORARY INTERRUPTION FOR SURGERY AND OTHER
INTERVENTIONS
- ELIQUIS should be discontinued at least
48 hours prior to elective surgery or invasive procedures with a
moderate or high risk of unacceptable or clinically significant
bleeding. ELIQUIS should be discontinued at least 24 hours prior to
elective surgery or invasive procedures with a low risk of bleeding
or where the bleeding would be noncritical in location and easily
controlled. Bridging anticoagulation during the 24 to 48 hours
after stopping ELIQUIS and prior to the intervention is not
generally required. ELIQUIS should be restarted after the surgical
or other procedures as soon as adequate hemostasis has been
established.
DRUG INTERACTIONS
- Strong Dual Inhibitors of CYP3A4 and
P-gp: Inhibitors of cytochrome P450 3A4 (CYP3A4) and
P-glycoprotein (P-gp) increase exposure to apixaban and increase
the risk of bleeding. For patients receiving ELIQUIS doses of 5 mg
or 10 mg twice daily, reduce the dose of ELIQUIS by 50% when
ELIQUIS is coadministered with drugs that are strong dual
inhibitors of CYP3A4 and P-gp (e.g., ketoconazole, itraconazole,
ritonavir, or clarithromycin). In patients already taking 2.5 mg
twice daily, avoid coadministration of ELIQUIS with strong dual
inhibitors of CYP3A4 and P-gp.
- Strong Dual Inducers of CYP3A4 and
P-gp: Avoid concomitant use of ELIQUIS with strong dual
inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine,
phenytoin, St. John’s wort) because such drugs will decrease
exposure to apixaban and increase the risk of stroke and other
thromboembolic events.
- Anticoagulants and Antiplatelet
Agents: Coadministration of antiplatelet agents, fibrinolytics,
heparin, aspirin, and chronic NSAID use increases the risk of
bleeding. APPRAISE-2, a placebo-controlled clinical trial of
apixaban in high-risk post-acute coronary syndrome patients treated
with aspirin or the combination of aspirin and clopidogrel, was
terminated early due to a higher rate of bleeding with apixaban
compared to placebo.
PREGNANCY CATEGORY B
- There are no adequate and
well-controlled studies of ELIQUIS in pregnant women. Treatment is
likely to increase the risk of hemorrhage during pregnancy and
delivery. ELIQUIS should be used during pregnancy only if the
potential benefit outweighs the potential risk to the mother and
fetus.
Please see full Prescribing Information, including BOXED
WARNINGS and Medication Guide, available at
www.bms.com.
About ACROPOLIS™
ACROPOLIS™ (Apixaban ExperienCe Through
Real-WOrld POpuLatIon
Studies) is the Eliquis (apixaban) global real-world data
program designed to generate additional evidence from routine
clinical practice settings to further inform healthcare decision
makers, including healthcare providers and payers. The ACROPOLIS
program will include retrospective, outcomes-based analyses from
over 10 databases around the world, including medical records,
medical and pharmacy health insurance claims data, and national
health data systems.
Analyses of real-world data allow for a broader understanding of
patient outcomes associated with Eliquis outside of the clinical
trial setting, as well as insight into other measures of healthcare
delivery, such as hospitalization and costs.
About ARISTOTLE
ARISTOTLE (Apixaban for Reduction In
STroke and Other ThromboemboLic
Events in Atrial Fibrillation) was designed to evaluate the
efficacy and safety of Eliquis versus warfarin for the prevention
of stroke or systemic embolism. In ARISTOTLE, 18,201 patients were
randomized (9,120 patients to Eliquis and 9,081 to warfarin).
ARISTOTLE was an active-controlled, randomized, double-blind,
multi-national trial in patients with nonvalvular atrial
fibrillation or atrial flutter, and at least one additional risk
factor for stroke. Patients were randomized to treatment with
Eliquis 5 mg orally twice daily (or 2.5 mg twice daily in selected
patients, representing 4.7 percent of all patients) or warfarin
(target INR range 2.0-3.0), and followed for a median of 1.8
years.
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a
worldwide collaboration to develop and commercialize apixaban, an
oral anticoagulant discovered by Bristol-Myers Squibb. This global
alliance combines Bristol-Myers Squibb's long-standing strengths in
cardiovascular drug development and commercialization with Pfizer’s
global scale and expertise in this field.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube and Facebook.
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, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.pfizer.com. In
addition, to learn more, please visit us on www.pfizer.com and
follow us on Twitter at @Pfizer and @PfizerNews, LinkedIn, YouTube
and like us on Facebook at Facebook.com/Pfizer.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding product development. Such forward-looking statements
are based on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that
affect Bristol-Myers Squibb's business, particularly those
identified in the cautionary factors discussion in Bristol-Myers
Squibb's Annual Report on Form 10-K for the year ended December 31,
2016, in our Quarterly Reports on Form 10-Q and our Current Reports
on Form 8-K. Bristol-Myers Squibb undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise.
Pfizer Disclosure Notice
The information contained in this release is as of August 18,
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 Eliquis
(apixaban), 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 clinical
trial commencement and completion dates as well as the possibility
of unfavorable clinical trial results, including unfavorable new
clinical data and additional analyses of existing clinical data;
decisions by regulatory authorities regarding labeling and other
matters that could affect the availability or commercial potential
of Eliquis; 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 SEC and available at www.sec.gov and
www.pfizer.com.
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