The US Food and Drug Administration (FDA) has accepted to review Bristol-Myers Squibb Company and Pfizer Inc.'s supplemental New Drug Application (sNDA) for Eliquis (apixaban), for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is March 15, 2014.
The submission is supported by the ADVANCE-1, ADVANCE-2, and ADVANCE-3 clinical trials, part of the EXPANSE clinical trial programme. These trials randomized nearly 12,000 patients and assessed the safety and efficacy of Eliquis compared to enoxaparin. ADVANCE-1 and ADVANCE-2 studied patients undergoing elective total knee replacement, and ADVANCE-3 studied patients undergoing elective hip replacement.
Venous thromboembolism, or 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. Patients undergoing major orthopaedic surgery, including total knee or total hip replacement, are at high risk for VTE.
Eliquis (apixaban) is an oral direct Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis prevents 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 (which includes 28 member states plus Iceland and Norway), Japan and a number of other countries around the world. Eliquis is approved for prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery in the European Union (which includes 28 member states plus Iceland and Norway) and a number of other countries around the world. Eliquis is not approved for this indication in the US.
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialise Eliquis, 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.
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.
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