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Eliquis (Apixaban) Wins Approval to Reduce Risk of Blood Clots After Hip- or Knee-Replacement Surgery
The FDA has approved a supplemental new drug application (sNDA) for Eliquis (apixaban, Bristol-Myers Squibb/Pfizer) 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.
Apixaban is an oral, selective inhibitor of Factor Xa, a key blood- clotting protein. By inhibiting Factor Xa, apixaban decreases thrombin generation and blood clot formation.
The full prescribing information for Eliquis (apixaban) 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.
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 the 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, an estimated 719,000 total knee-replacement surgeries and 332,000 hip-replacement surgeries are performed each year in the U.S. Patients undergoing hip- or knee-replacement surgery without thromboprophylaxis are at risk for developing DVT and PE. Current guidelines recommend the use of anticoagulants for the prophylaxis of DVT and PE for most patients undergoing orthopedic surgery.
The FDA’s approval of the sNDA for Eliquis was supported by positive data from three clinical studies of apixaban (the ADVANCE clinical trial program) in a total of 5,770 subjects.
In December 2013, the FDA accepted for review another sNDA for Eliquis for the treatment of DVT and PE, and for reducing the risk of recurrent DVT and PE.
Eliquis is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The drug is also indicated 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.
Source: Bristol-Myers Squibb; March 14, 2014.