Bristol-Myers Squibb Company
(NYSE: BMY) and
. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Supplemental New Drug Application (sNDA) for
(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 program. These trials randomized nearly 12,000 patients and assessed the safety and efficacy of
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 orthopedic surgery, including total knee or total hip replacement, are at high risk for VTE. In fact, VTE occurs in 40 to 60 percent of patients undergoing orthopedic surgery who do not receive preventive care.
(apixaban) is an oral direct Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein,
prevents thrombin generation and blood clot formation.
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.
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.
is not approved for this indication in the U.S.
IMPORTANT SAFETY INFORMATION FOR ELIQUIS
BOXED WARNING: DISCONTINUING ELIQUIS IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE.
Discontinuing ELIQUIS places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients with nonvalvular atrial fibrillation. If anticoagulation with ELIQUIS must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered .
- Active pathological bleeding