ELIQUIS®▼ (apixaban) Receives a Fast-Tracked Positive Final Appraisal
Determination (FAD) From NICE for the Prevention of Stroke and Systemic
Embolism in Patients With Non-Valvular Atrial Fibrillation With One or More
UXBRIDGE and WALTON OAKS, England, January 23, 2013
UXBRIDGE and WALTON OAKS, England, January 23, 2013 /PRNewswire/ --
F O R U K JO U R NAL IS T S O NL Y.
• Apixaban is the only novel oral anticoagulant so far appraised by NICE in
this indication to go straight to FAD
• Atrial fibrillation (AF) affects 1.2 million people in the UK ^1 ,
putting them at a five-fold risk of serious stroke ^2
Bristol-Myers Squibb and Pfizer Ltd. today announced that the National
Institute for Health and Clinical Excellence (NICE) has issued a fast-tracked
Final Appraisal Determination (FAD) recommending the oral anticoagulant
Eliquis (apixaban) as an option for preventing stroke and systemic embolism,
in patients with non-valvular atrial fibrillation (AF) with one or more risk
factors. ^3 The NICE appraisal committee concluded that apixaban was cost
effective and more clinically effective for reducing stroke and systemic
embolism; and resulted in fewer bleeds than warfarin. ^3
The Single Technology Appraisal (STA) for apixaban has been fast-tracked
straight to FAD, bypassing the need for draft guidance for consultation.
Apixaban is the only oral novel anticoagulant (NOAC) so far appraised by NICE
in this indication to go straight to FAD. The FAD forms the basis of the final
guidance to the NHS in England and Wales and, pending no change, is expected
in February, 2013. Once the final guidance is published the NHS will be
legally obliged to implement it within 90 days.
Atrial fibrillation is the most common heart rhythm disorder and is thought to
cause approximately 12,500 strokes in the UK/England every year. ^4 The risk
of strokes can be reduced through adequate anticoagulation, ^5 or thinning of
the blood, so it is less likely to clot. ^6 In the UK, 1.2 million people have
AF ^1 and the prevalence is believed to be growing. ^7 The NHS estimates that
46 percent of AF patients who would benefit from anticoagulation therapy are
not currently receiving it. ^8 NHS Improvement estimates that up to 4,500
strokes per year and 3,000 deaths may be preventable through improved services
and optimal therapy. ^8
"This positive FAD is excellent news for patients with atrial fibrillation in
England and Wales," said Trudie Lobban MBE, founder and CEO of the Atrial
Fibrillation Association. "Many patients with atrial
anticoagulantwarfarin,whichrequireson-goingINR monitoring and can have
undesirable interactions with other drugs and diet.Having the choice of
effective new treatments which do not require INR monitoring can help reduce
the impact that atrial fibrillation has on patients, their families and
For non-valvular AF related strokes, the NOAC apixaban has been shown to be
more effective than warfarin at preventing strokes or systemic embolism, has
been associated with less major bleeding and resulted in more lives saved. ^9
Amadou Diarra, VP, UK and Ireland, from Bristol-Myers Squibb said on behalf of
the Alliance: "NICE's fast-tracked recommendation confirms the value of
apixaban as a cost-effective oral anticoagulant for the prevention of stroke
in patients affected by atrial fibrillation. The risk of stroke in these
patients is a serious public health concern and through this new treatment
option, the Alliance of Bristol-Myers Squibb and Pfizer remains committed to
helping reduce the incidence of stroke in patients living with non-valvular
AF. Additionally, we are pleased that the novel oral anticoagulants have been
selected as a priority area within the NHS Innovation Health and Wealth
initiative, seeking to ensure patients have faster and more consistent access
to NICE-recommended medicines. We look forward to working with the NHS and
other partners to ensure that, where clinically appropriate, patients are
provided with rapid access to apixaban, which has been shown to prevent
strokes, reduce bleeds and be potentially life-saving compared to the current
standard of care, warfarin."
# # #
About Apix a b an
Apixaban was licensed for use in the European Union in November 2012 for the
prevention of stroke and systemic embolism in adult patients with non-valvular
AF and one or more risk factors such as prior strokeor transient ischaemic
attack;age75 years or older; hypertension; diabetes mellitus; symptomatic
heart failure (NYHA Class ≥ II).
Apixaban's licence for stroke prevention in non-valvular AF is supported by
the pivotal ARISTOTLE and AVERROES studies. ^9,10 ARISTOTLE evaluated apixaban
vs. warfarin in 18,201 patients with non-valvular AF who were suitable for
warfarin, and AVERROES evaluated apixaban vs. aspirin in 5,599 patients with
non-valvular AF who were considered unsuitable for warfarin. ^9 , ^10
Apixaban is also licensed for the prevention of venous thromboembolic events
in adult patients who have undergone elective hip or knee replacement surgery.
About Atrial Fibrill a tion (AF)
AF is the most common type of heart arrhythmia ^4 where the heart beats
irregularly allowing blood to pool in the left atrium which may result in the
formation of a clot. ^6 These clots can break off and travel through the
bloodstream to smaller blood vessels in the brain where they can cause a
stroke.6 Stroke due to AF is more severe and stroke recurrence is more
frequent in patients with AF than in patients without AF. Additionally,
ischaemic strokes associated with AF are nearly twice as likely to be fatal as
non-AF related strokes. ^11 Because AF is often asymptomatic and may be
clinically undetected, the stroke risk attributed to AF may be substantially
underestimated. ^2 Up to one-third of patients with AF report no obvious
symptoms. ^12 The risk of stroke can be reduced substantially through the
recognition of AF8 and adequate pharmacological anticoagulation therapy. ^5
About t h e Br i sto l - Myers Sq u i b b /Pf iz e r Collaboration
In 2007, Bristol-Myers Squibb and Pfizer entered into a worldwide
collaboration to develop and commercialise 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 commercialisation with Pfizer's global scale and expertise in
About Brist o l - My e rs S q uibb
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.
Pfi z e r: Wor k i n g T og e th e r for a Hea l t h ier World™
At Pfizer, we apply science and our global resources to improve health and
well-being at every stage of life. We strive to set the standard for quality,
safety and value in the discovery, development and manufacturing of medicines
for people and animals.Our diversifiedglobal healthcareportfolio includes
human and animal biologic and small molecule medicines and vaccines, as well
as many of the world's best-knownconsumer products.Every
wellness,prevention,treatmentsandcuresthat challenge the most feared
diseases of our time. Consistent with our responsibility as the world's
leading biopharmaceuticalcompany, we also
collaboratewithhealthcareproviders,governmentsandlocal 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. In the UK, Pfizer has its business headquarters in Surrey and
is a major supplier of medicines to the NHS. To learn more about our
commitments, please visit us at http://www.pfizer.co.uk .
^1 National Institute for Health and Clinical Excellence. Medical Technology
Guidance. SCOPE. WatchBP Home A for diagnosing and monitoring hypertension and
detecting atrial fibrillation. Available at:
http://www.nice.org.uk/nicemedia/live/13570/60600/60600.pdf Last accessed:
^2 Roger VL, et al. Heart Disease and Stroke Statistics-2011 Update: A Report
From The American Heart Association. Ci r cula ti on . 2011 Feb 1;
^3 National Institute for Health and Clinical Excellence, Final appraisal
determination Apixaban for preventing stroke and systemic embolism in people
with non-valvular atrial fibrillation, Issue January 2013
^4 NHS Improvement - Atrial Fibrillation. Available at:
http://www.improvement.nhs.uk/heart/AboutAF.aspx Last accessed: 03/01/2013
^5 Ahmad Y and Lip G. Stroke prevention in atrial fibrillation: Where are we
now? C l in Med Ins i ghts Car d iol 2012; 6:65-78.
^6 The Stroke Association. Atrial Fibrillation (AF) and stroke. Factsheet 26.
Last accessed: 03/01/2013
^7 Banach M, et al. The significance of preoperative atrial fibrillation in
patients undergoing cardiac surgery: preoperative atrial fibrillation - still
underestimated opponent. Eu ro p a c e 2008 10: 1266 - 70.
^8 Atrial Fibrillation - detection and optimal therapy in primary care. NHS
Stroke Improvement Programme.
^9 Granger CB, et al. Apixaban versus warfarin in patients with atrial
fibrillation. N E n g l J M e d 2011; 365:981-92.
^10 Connolly SJ et al. Apixaban in patients with atrial fibrillation. N E ng
l J M e d 2011 364(9):806-17.
^11 Huey et al. Stroke Severity in Atrial Fibrillation. The Framingham Study.
St r o ke 1996; 27 (10): 1760-4.
^12 Savelieva I et al. Silent Atrial Fibrillation - Another Pandora's Box. P
ac i n g C l in E l ec t r o p hy s i o l. 2000 Feb; 23(2):145-8.
Contact: Contacts: Pfizer Ltd., Pfizer Press Office, 0845-300-8033,
pressofficeUK@pfizer.com; Bristol-Myers Squibb, Bridget Mullahy,
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