Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc.
(NYSE:PFE) today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has adopted a positive opinion recommending that Eliquis
(apixaban) be granted marketing authorization for the treatment of
DVT (deep vein thrombosis) and PE (pulmonary embolism), and the
prevention of recurrent DVT and PE, in adults. The CHMP’s positive
opinion will now be reviewed by the European Commission (EC). The
decision on whether to approve Eliquis for this indication will be
made by the EC and will be applicable to all European Union member
states plus Iceland and Norway.
The positive opinion was based on the results from the pivotal
AMPLIFY and AMPLIFY-EXT studies. AMPLIFY (Apixaban for the
initial Management of PuLmonary
embolIsm and deep vein thrombosis as First-line
therapY), a randomized, double-blind, multicenter trial,
included 5,395 patients (2,691 were randomized to Eliquis and 2,704
were randomized to standard of care, which was initial enoxaparin
treatment overlapped by warfarin therapy) with confirmed
symptomatic DVT or PE requiring treatment for six months, and
evaluated Eliquis therapy compared to standard of care. The primary
efficacy endpoint was the composite endpoint of recurrent
symptomatic VTE (nonfatal DVT or nonfatal PE) or VTE-related death.
The primary safety endpoint was the incidence of major bleeding
compared to standard of care.
AMPLIFY-EXT (Apixaban after the initial Management
of PuLmonary embolIsm and deep vein thrombosis
with First-line therapY-EXTended Treatment), a
randomized, double-blind, multicenter trial, included 2,486
patients (842 were randomized to Eliquis 2.5 mg, 815 were
randomized to Eliquis 5 mg and 829 were randomized to placebo) with
prior VTE who had completed six to 12 months of anticoagulation
treatment for DVT or PE, and evaluated Eliquis therapy compared to
placebo. The primary efficacy endpoint was reduction of the
composite of symptomatic, recurrent VTE and death from any cause.
The primary safety endpoint was the incidence of major
bleeding.
IMPORTANT SAFETY
INFORMATION
WARNINGS: (A) DISCONTINUING
ELIQUIS IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION WITHOUT
ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE, (B)
SPINAL/EPIDURAL HEMATOMA
(A) Discontinuing ELIQUIS places
patients at an increased risk of thrombotic events. An increased
rate of stroke was observed following discontinuation of ELIQUIS in
clinical trials in patients with nonvalvular atrial fibrillation.
If anticoagulation with ELIQUIS must be discontinued for a reason
other than pathological bleeding, coverage with another
anticoagulant should be strongly considered.
(B) When neuraxial anesthesia
(epidural/spinal anesthesia) or spinal puncture is employed,
patients anticoagulated or scheduled to be anticoagulated with low
molecular weight heparins, heparinoids, or Factor Xa inhibitors for
prevention of thromboembolic complications are at risk of
developing an epidural or spinal hematoma which can result in
long-term or permanent paralysis.
The risk of these events may be
increased by the use of indwelling epidural catheters for
administration of analgesia or by the concomitant use of drugs
affecting hemostasis such as nonsteroidal anti-inflammatory drugs
(NSAIDs), platelet aggregation inhibitors, or other anticoagulants.
The risk also appears to be increased by traumatic or repeated
epidural or spinal puncture.
Monitor patients for signs and symptoms
of neurologic impairment. If neurologic compromise is noted, urgent
treatment is necessary. Consider the potential benefit versus risk
before neuraxial intervention in patients anticoagulated or to be
anticoagulated for thromboprophylaxis.
CONTRAINDICATIONS
- Active pathological bleeding
- Severe hypersensitivity reaction to
ELIQUIS (apixaban) (e.g., anaphylactic reactions)
WARNINGS AND PRECAUTIONS
- Increased Risk of Stroke with
Discontinuation of ELIQUIS in Patients with Nonvalvular Atrial
Fibrillation: Discontinuing 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 patients
with nonvalvular atrial fibrillation. If ELIQUIS must be
discontinued for a reason other than pathological bleeding,
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. Patients should be made aware of signs or
symptoms of blood loss and instructed to immediately report 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.
Hemodialysis does not appear to have a substantial impact on
apixaban exposure. Protamine sulfate and vitamin K would not be
expected to affect the anticoagulant activity of apixaban. There is
no experience with antifibrinolytic agents (tranexamic acid,
aminocaproic acid) in individuals receiving apixaban. There is
neither scientific rationale for reversal nor experience with
systemic hemostatics (desmopressin and aprotinin) in individuals
receiving apixaban. Use of procoagulant reversal agents such as
prothrombin complex concentrate, activated prothrombin complex
concentrate, or recombinant factor VIIa may be considered but has
not been evaluated in clinical studies. Activated charcoal reduces
absorption of apixaban thereby lowering apixaban plasma
concentrations.
- 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.
ADVERSE REACTIONS
The most common and most serious adverse reactions reported with
ELIQUIS (apixaban) 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
5 mg twice daily, the dose of ELIQUIS should be decreased when it
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 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.
- 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 DVT and PE
Venous thromboembolism, or VTE, encompasses two serious
conditions: deep vein thrombosis (DVT), a blood clot in a deep
vein, usually in the lower leg, thigh, or pelvis, which partially
or totally blocks the flow of blood; and pulmonary embolism (PE), a
blood clot that blocks one or more vessels in the lungs.
Approximately one million patients in the EU are diagnosed every
year with VTE. In the US, the number of adults with VTE is
projected to more than double from 0.95 million in 2006 to 1.82
million in 2050. Once a VTE has occurred, up to 10 percent of
people may have a VTE reoccurrence, which could potentially be
fatal.
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 to reduce the risk of stroke and systemic embolism in
patients with nonvalvular atrial fibrillation in the United States,
European Union, Japan and a number of other countries around the
world. Eliquis is approved for the prophylaxis of DVT which can
lead to PE in adult patients who have undergone elective hip or
knee replacement surgery in the United States, European Union and a
number of other countries around the world. Eliquis is not approved
for this indication in Japan.
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 Eliquis will receive approval
for these additional indications or, if approved, that these
additional indications will lead to increased commercial success.
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 June 27, 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 that involves
substantial risks and uncertainties about Eliquis’s (apixaban’s)
potential benefits and about potential additional indications for
Eliquis in the EU for the treatment of deep vein thrombosis (DVT)
and pulmonary embolism (PE) and the prevention of recurrent DVT and
PE in adults (the “potential additional indications”). Such risks
and uncertainties include, among other things, (i) whether and when
the European Commission (the “EC”) may approve the marketing
authorization application for the potential additional indications,
as well as the EC’s decisions regarding labeling and other matters
that could affect the availability or commercial potential of
the potential additional indications; (ii) the uncertainties
regarding the commercial success of the potential additional
indications in the EU; and (iii) 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 its subsequent reports on Form 10-Q and
Form 8-K.
Bristol-Myers SquibbMedia:Shelly Mittendorf,
609-480-2951shelly.mittendorf@bms.comorInvestors:Ranya
Dajani, 609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.comorPfizer Inc.Media:Jennifer
Kokell,
212-733-2596jennifer.kokell@pfizer.comorInvestors:Ryan
Crowe, 212-733-8160ryan.crowe@pfizer.com
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