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
"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
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
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.
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
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:
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.
WARNINGS AND PRECAUTIONS
TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS
PREGNANCY CATEGORY B
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
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
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
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