Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.
“Today’s FDA approval of Eliquis for DVT prophylaxis in patients who have undergone hip or knee replacement is a significant milestone for this important medicine, which is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation,” said Brian Daniels, M.D., senior vice president, global development and medical affairs, Bristol-Myers Squibb. “This approval reflects the continued commitment of the alliance to deliver new treatment options for patients and physicians.”
“As the number of hip and knee replacement surgeries performed in the U.S. continues to increase, the risk of DVT following these surgeries remains a concern for physicians,” said Steven J. Romano, M.D., senior vice president and Medicines Development Group Head, Global Innovative Pharmaceuticals Business, Pfizer Inc. “Eliquis provides patients and physicians with a new treatment option that offers twice daily oral dosing and no routine coagulation testing, and is broadly accessible through hospitals and managed health care formularies.”
The full Prescribing Information for Eliquis includes Boxed Warnings for the increased risk of stroke in patients with nonvalvular atrial fibrillation who discontinue Eliquis without adequate continuous anticoagulation; and for the increased risk of epidural or spinal hematoma, which may cause long-term or permanent paralysis, in patients using Eliquis and undergoing spinal epidural anesthesia or spinal puncture. Please see complete Boxed Warnings and additional Important Safety Information in this press release.
DVT, a blood clot that forms in a large vein, usually in the lower leg, thigh, or pelvis, can lead to PE when a portion or all of a blood clot breaks off and travels to the lungs, blocking one or more blood vessels. PE can lead to sudden death.
Based on recent data, each year in the U.S. an estimated 719,000 total knee replacement surgeries and 332,000 hip replacement surgeries are performed. Patients undergoing hip or knee replacement surgery without thromboprophylaxis are at risk for developing DVT and PE. Guidelines recommend the use of anticoagulants for the prophylaxis of DVT and PE for most patients undergoing orthopedic surgery.
“DVT, which may lead to PE, is a serious medical condition,” said Richard J. Friedman, M.D., FRCSC, Professor of Orthopaedic Surgery, Medical University of South Carolina. “The FDA approval of Eliquis gives U.S. orthopedic surgeons a new option for DVT prophylaxis in both hip and knee replacement surgery.”
This sNDA approval for Eliquis is supported by three clinical trials (the ADVANCE clinical trial program). The ADVANCE trials randomized more than 11,000 patients, with 5,770 receiving Eliquis and 5,755 receiving enoxaparin, to assess the safety and efficacy of Eliquis.
In December 2013, the FDA accepted for review another sNDA for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE.