ELIQUIS® (apixaban) Available in Canada for the Prevention of Venous Thromboembolism after Elective Hip or Knee Replacement
A new oral direct Factor Xa inhibitor
The alliance of Bristol-Myers Squibb and Pfizer Canada Inc. announced today that Eliquis® (apixaban), an oral treatment, is now available in Canada for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or knee replacement surgery.
“The development of VTE or pulmonary embolism is an important risk for patients having major orthopedic surgery such as total knee or hip replacement,” said Dr. John Eikelboom, Associate Professor, Department of Medicine at McMaster University in Hamilton, Ontario. “The approval of apixaban gives Canadian surgeons a new option to help prevent VTE in these patients. As an oral option for patients in hospital and once they return home after surgery, where most clotting complications can take place after they are discharged from hospital, apixaban offers patients an alternative to an injected anticoagulant.”[i]
Orthopaedic surgery is one of the most common elective surgeries in Canada, with approximately 72 000 hip or knee replacements performed each year, equivalent to a 0.3% incidence.[ii]
A new oral direct Factor Xa inhibitor, Eliquis has already been approved for the prevention of VTE in the European Union and other countries.
The approval of Eliquis by Health Canada is based on the ADVANCE clinical trials.[iii] [iv] [v] These trials randomised 11,659patients iii and assessed the efficacy and bleeding risk of apixaban compared to enoxaparin. The primary efficacy endpoint of the ADVANCE trials, which studied patients undergoing elective total knee or hip replacement, was defined as the composite of asymptomatic and symptomatic deep vein thrombosis (DVT), nonfatal pulmonary embolism (PE), and death from any cause during study treatment. The principal safety measure in the trials was the composite of major and clinically relevant non-major bleeding.
“By making Eliquis available to doctors and their patients in Canada – an important milestone for the Alliance – we hope to help reduce the burden of blood clots in patients undergoing elective hip and knee replacement,” said Dr. Bernard Prigent, Vice-President and Medical Director, Pfizer Canada.
“We are confident that our shared resources and leadership in developing Eliquis will be welcomed by Canadian physicians since it brings a new treatment alternative for their patients,” added Dr. Mitch Shulman, Vice President, Medical Affairs, Bristol-Myers Squibb.
About Venous Thromboembolism
VTE encompasses two serious conditions: Deep Vein Thrombosis (DVT), a blood clot in a vein, usually in the leg, that partially or totally blocks the flow of blood; and Pulmonary Embolism (PE), 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 the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize ELIQUIS®, an investigational 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 Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol-Myers Squibb Canada is a leading provider of medicines to fight cancer, cardiovascular and metabolic disorders, infectious diseases (including HIV/AIDS), nervous system diseases and serious mental illness. Bristol-Myers Squibb Canada's operations are headquartered in Montreal, Quebec.
About Pfizer Canada
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc, the world's leading biopharmaceutical company. Pfizer Canada has nearly 3,000 employees working at six facilities across Canada and in many other communities in every province. They are the heart of Pfizer’s ability to contribute significantly to Canadians’ health and economic well-being through the company’s provision of prescription and non-prescription medicines, vaccines, generic medicines, and animal health products, as well as its investments and job-creation in research and development and manufacturing. Well-known brands from Pfizer include the prescription medicines Celebrex, Champix, Viagra, Premarin and Lipitor and the non-prescription products Advil, Dristan, Dimetapp, Chapstick, Centrum and Caltrate.
Every day, Pfizer Canada employees work to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives that it takes more than medication to our community partnerships, to our belief to be truly healthy. To learn more about Pfizer's More Than MedicationTM philosophy and programs, visit www.morethanmedication.ca. To learn more about Pfizer Canada, visit www.pfizer.ca.
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ELIQUIS® is a trademark of Bristol-Myers Squibb Inc.
More Than MedicationTMis a trademark of Pfizer Canada Inc.
For more information, please contact:
Christina Antoniou Monica Flores
Pfizer Canada Bristol-Myers Squibb Canada
1-866-9PFIZER (734937) (514) 333-3845
[i]Product Monograph (page 3), December 13, 2011.
[ii]Hip and Knee Replacements in Canada, 2008-09 Annual Report, Canadian Joint Replacement Registry at the Canadian Institute for Health Information: p. vii. Ottawa, available at: https://secure.cihi.ca/estore/productFamily.htm?pf=PFC1063&lang=en&media=0. Last accessed on 16 February, 2012.
[iii]Lassen MR et al. N Engl J Med 2009; 361 (6): 594-604
Apixaban or enoxaparin for thromboprophylaxis after knee replacement. Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa0810773. Last accessed on 16 February, 2012
[iv] Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P; ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet 2010;375:807-15. Available at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)62125-5/abstract. Last accessed on 16 February, 2012
[v] Lassen MR, et al. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med 2010;363:2487-98.Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1006885. Last accessed on 16 February, 2012