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 Risk Factors PR Newswire 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 ^3 The Single Technology Appraisal (STA) for apixaban has been fast-tracked straight to FAD, bypassing the need for draft guidance for consultation.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 fibrillationarecurrentlytreatedwiththe 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 carers." 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 this field. 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 day,Pfizercolleaguesworkto advance 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: 03/01/13 ^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; 123(4):e18-e209. ^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. Available at: http://www.stroke.org.uk/sites/default/files/Atrial%20fibrillation%20(AF)%20and%20stroke.pdf 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, +44-(0)1895-52-3642, Bridget.Mullahy@bms.com
ELIQUIS®▼ (apixaban) Receives a Fast-Tracked Positive Final Appraisal Determination (FAD) From NICE for the Prevention of
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