FDA approves Eliquis for DVT prophylaxis
PRINCETON, N.J. and NEW YORK — Bristol-Myers Squibb Co. and Pfizer announced that the Food and Drug Administration approved a supplemental new drug application for Eliquis (apixaban). The drug is a preventive treatment for deep vein thrombosis, which can lead to pulmonary embolism for patients who have had hip or knee replacement surgery.
“As the number of hip and knee replacement surgeries performed in the United States continues to increase, the risk of DVT following these surgeries remains a concern for physicians,” said Steven J. Romano, M.D., SVP and medicines development group head, Global Innovative Pharmaceuticals Business, Pfizer. “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 healthcare formularies.”
An estimated 719,000 total knee replacement surgeries and 332,00 hip replacement surgeries are performed, the company said.
“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.”