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FDA approves Eliquis for DVT prophylaxis after TJA
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The FDA has approved a supplemental new drug application for Eliquis for the prophylaxis of deep vein thrombosis in patients who have undergone total hip or knee arthroplasty.
In December 2013, the FDA accepted the supplemental new drug application for apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) for the treatment of and reduction of the risk of recurrent deep vein thrombosis (DVT) and pulmonary embolism.
“The 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,” Brian Daniels, MD, senior vice president, global development and medical affairs of Bristol-Myers Squibb, stated in a company press release. “This approval reflects the continued commitment of the alliance to deliver new treatment options for patients and physicians.”
Steven J. Romano, MD, senior vice president and medicines development group head, global innovative pharmaceuticals business for Pfizer stated in the release that apixaban offers patients and physicians twice daily oral dosing and no routine coagulation testing.