- Eliquis demonstrated noninferiority in
the primary efficacy endpoint of recurrent symptomatic venous
thromboembolism (VTE) or VTE-related death versus
enoxaparin/warfarin in the AMPLIFY trial
- Eliquis demonstrated superiority in the
primary safety endpoint of major bleeding versus
enoxaparin/warfarin in the AMPLIFY trial
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE:
PFE) today announced the U.S. Food and Drug Administration (FDA)
has approved a Supplemental New Drug Application (sNDA) for Eliquis
for the treatment of DVT and PE, and for the reduction in the risk
of recurrent DVT and PE following initial therapy. Combined, DVT
and PE are known as VTE. It is estimated that every year,
approximately 900,000 Americans are affected by DVT and PE.
“We are pleased that Eliquis is now available as an effective
treatment option for DVT and PE,” said Douglas Manion, M.D., Head
of Specialty Development, Bristol-Myers Squibb. “Eliquis offers
oral dosing, no routine coagulation testing, and does not require
the use of a parenteral anticoagulant or bridging during
initiation.”
“DVT, which may lead to PE, can be a serious medical condition,
with PE requiring immediate medical attention for treatment. Once a
VTE has occurred, approximately 33 percent of patients are at risk
of a recurrence within 10 years,” said Steve Romano, senior vice
president, Head of Medicines Development Group for Global
Innovative Pharmaceuticals, Pfizer Inc. “The Bristol-Myers Squibb
and Pfizer alliance is committed to delivering important treatment
options to patients and physicians.”
The full Prescribing Information for Eliquis includes Boxed
Warnings for the increased risk of thrombotic events in patients
who prematurely discontinue Eliquis; and for the increased risk of
epidural or spinal hematoma, which may cause long-term or permanent
paralysis, in patients using Eliquis and undergoing spinal epidural
anesthesia or spinal puncture.
Eliquis increases the risk of bleeding and can cause serious,
potentially fatal, bleeding. Please see the complete Boxed Warnings
and additional Important Safety Information in this press
release.
The FDA approval of Eliquis for the treatment of DVT and PE, and
for the reduction in the risk of recurrent DVT and PE following
initial therapy, is based on data from the global AMPLIFY and
AMPLIFY-EXT studies.
The AMPLIFY study, a randomized, double-blind trial, was
designed to demonstrate the efficacy and safety of Eliquis for the
treatment of DVT and PE, and included patients with confirmed
symptomatic DVT or PE (2,609 for Eliquis and 2,635 for standard of
care, which was initial enoxaparin treatment for at least five
days, overlapped by warfarin therapy [International Normalized
Ratio (INR) range 2.0-3.0] orally for six months).
In the AMPLIFY study, Eliquis 10 mg twice daily for one week
followed by 5 mg twice daily for six months demonstrated efficacy
comparable to standard of care in treating DVT and PE patients for
the primary efficacy composite endpoint of recurrent, symptomatic
VTE, or VTE-related death (2.3% vs. 2.7%, relative risk, 0.84; 95%
confidence interval [CI], 0.60 to 1.18; P-value<0.0001 for
noninferiority).
Eliquis demonstrated superiority in the primary safety endpoint
of major bleeding versus standard of care (0.6% vs. 1.8%, relative
risk 0.31; 95% CI, 0.17 to 0.55; P<0.0001 for superiority).
Major bleeding was defined as clinically overt bleeding that was
accompanied by one or more of the following: a decrease in the
hemoglobin level of 2 g/dL or more; a transfusion of two or more
units of packed red blood cells; bleeding that occurred in at least
one of the following critical sites: intracranial, intraspinal,
intraocular, pericardial, intra-articular, intramuscular with
compartment syndrome, retroperitoneal; or bleeding that was
fatal.
For the secondary safety endpoint in the AMPLIFY study, the
event rates for clinically relevant nonmajor bleeding (CRNM) were
fewer in Eliquis-treated patients compared to standard of
care-treated patients (3.9% vs. 8.0%). CRNM was defined as overt
bleeding that did not meet the criteria for major bleeding but was
associated with a medical intervention, contact with a physician,
interruption of the study drug, or discomfort or impairment in
carrying out daily activities.
In AMPLIFY, the discontinuation rate due to bleeding events was
0.7% in the Eliquis-treated patients compared to 1.7% in
enoxaparin/warfarin-treated patients.
About DVT and PE
DVT is a blood clot in a vein, usually in the lower leg, thigh,
or pelvis, which partially or totally blocks the flow of blood. PE
is a blood clot blocking one or more vessels in the lungs. DVT
causes multiple symptoms including pain, swelling, and redness, and
more importantly, can progress to PE, which carries the risk of
sudden death.
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, including results from seven Phase 3 clinical
trials.
ELIQUIS Important Safety Information
Indications
ELIQUIS is indicated to reduce the risk of stroke and systemic
embolism in patients with nonvalvular atrial fibrillation.
ELIQUIS is indicated 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.
ELIQUIS is indicated for the treatment of DVT and PE, and to
reduce the risk of recurrent DVT and PE following initial
therapy.
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 anti-platelet 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 CYP3A4 and P-gp increase exposure to
apixaban and increase the risk of bleeding. For patients receiving
ELIQUIS doses greater than 2.5 mg twice daily, the dose of ELIQUIS
should be decreased by 50% when it is coadministered with drugs
that are strong dual inhibitors of CYP3A4 and P-gp (e.g.,
ketoconazole, itraconazole, ritonavir, or clarithromycin). For
patients receiving ELIQUIS at a dose of 2.5 mg twice daily, avoid
coadministration 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 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, please visit www.bms.com.
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. To learn more, please visit us at
www.pfizer.com.
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. Among other
risks, there can be no guarantee that the approval of these
additional indications in the U.S. will lead to increased
commercial success or that Eliquis will be approved for any other
additional indications. 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,
2013, 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 21,
2014. 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’s (apixaban’s) potential benefits and about additional
indications for Eliquis in the U.S. for the treatment of DVT and
PE, and for the reduction in the risk of recurrent DVT and PE
following initial therapy, 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
regarding the commercial success of the additional indications in
the U.S.; whether and when regulatory authorities in other
jurisdictions will approve applications for these potential
additional indications, as well as their decisions regarding
labeling and other matters that could affect the availability or
commercial potential of such potential additional indications; 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, 2013 and in our subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward--10-Looking Information 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.
Bristol-Myers SquibbMedia:Danielle Halstrom,
609-252-3403danielle.halstrom@bms.comInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comRyan Asay,
609-252-5020ryan.asay@bms.comorPfizer Inc.Media:Jennifer
Kokell, 212-733-2596jennifer.kokell@pfizer.comInvestors:Ryan
Crowe, 212-733-8160ryan.crowe@pfizer.com
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