Health Canada Approves Expanded Indication for ELIQUIS (apixaban)
KIRKLAND, QC, Nov. 26, 2014 /CNW/ - ELIQUIS® (apixaban) has received Health Canada approval for the treatment of venous thromboembolic events (VTE) and the prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.1
Venous thromboembolism (VTE), encompasses two serious conditions: DVT and PE.2 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.2 DVT causes multiple symptoms including pain, swelling, and redness, and more importantly, can progress to PE, which carries the risk of sudden death.3,4,5
PE occurs when a blood clot in the deep veins of the leg or pelvis detaches and travels to the lung via the heart, blocking one or more of the pulmonary arteries. Without immediate treatment, the resulting loss of lung function can cause sudden death or long-term damage to the lungs and other vital organs. VTE affects about 45,000 Canadians per year.6
"VTE is one of the most common cardiovascular disorders in Canada, affecting about five per cent of people in their lifetime," says Dr. John Eikelboom, Associate Professor, Department of Medicine at McMaster University. "DVT, along with PE, are very serious conditions and it is important we have novel therapies like ELIQUIS for treatment."
ELIQUIS is an oral anticoagulant which selectively inhibits Factor Xa. In Canada, ELIQUIS was first approved in 2011 for the prevention of VTE in adult patients who have undergone elective total hip or knee replacement surgery. In 2012, ELIQUIS was approved for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF).
Health Canada's approval of ELIQUIS' expanded indication is based on data from global studies (AMPLIFY and AMPLIFY-EXT). AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY) was designed to demonstrate the efficacy and safety of ELIQUIS for the treatment of DVT and PE versus subcutaneous enoxaparin followed by warfarin orally for six months.7 More than 5,000 patients participated in the AMPLIFY study.
AMPLIFY-EXT (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended treatment) was designed to demonstrate the efficacy and safety of ELIQUIS compared to placebo for the prevention of recurrent DVT and PE in at-risk patients following six to 12 months of anticoagulant treatment for DVT and/or PE.8 Approximately 2,500 patients participated in the AMPLIFY-EXT study.
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, a novel 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 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 conditions. For more information, please visit www.bms.com.
About Pfizer Canada Inc.
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified health care portfolio includes some of the world's best known and most prescribed medicines and vaccines. Historically, Pfizer Inc. has invested more than US $7 billion toward developing safe and effective medicines. At Pfizer, we're working together for a healthier world. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on Twitter (twitter.com/PfizerCA) or Facebook (facebook.com/Pfizer.Canada).
1 Eliquis. Product Monograph. November 2014.
2 Tapson VF. Acute Pulmonary Embolism. N Engl J Med. 2008;358:1037-1052.
3 Moll S, Mackman N. Venous Thromboembolism: A Need for More Public Awareness and Research Into Mechanisms. Arterioscler Thromb Vasc Biol. 2008;28(3):373-379.
4 Deep Vein Thrombosis (DVT) / Pulmonary Embolism (PE) - Blood Clot Forming in a Vein. Centers for Disease Control and Prevention. 25 September, 2012. Available at: http://www.cdc.gov/ncbddd/dvt/facts.html. Accessed January 17, 2013.
5 Goldhaber SZ, Bounameaux H. Pulmonary Embolism and deep vein thrombosis. Lancet 2012: 379:1835-46.
6 Tagalakis V et al. Incidence of and mortality from venous thromboembolism in a real-world population: the Q-VTE Study Cohort. Am J Med 2013; 126: 13–21.
7 Agnelli G et al. Oral apixaban for the acute treatment of venous thromboembolism. N Engl J Med 2013; 369: 799-808.
8 Agnelli G et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med 2013: 699-708.
SOURCE: Pfizer Canada Inc.
Renseignements: Karley Ura, NATIONAL Public Relations, 416-848-1425, [email protected]; Christina Antoniou, Corporate Affairs, Pfizer Canada Inc., 1-866-9PFIZER, [email protected]; Monica Flores, Bristol-Myers Squibb Canada, 514-333-3845, [email protected]