Apixaban now approved to reduce risk of blood clots after hip, knee surgery

March 22, 2014

FDA has approved apixaban (Eliquis, Bristol-Myers Squibb and 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.

FDA has approved apixaban (Eliquis, Bristol-Myers Squibb and 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.

“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, MD, senior vice president and medicines development group head, Global Innovative Pharmaceuticals Business, Pfizer, in a press release. “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.”

The new indication for apixaban is supported by 3 clinical trials - the ADVANCE clinical trial program. The ADVANCE trials randomly assigned more than 11,000 patients to assess the safety and efficacy of apixaban, with 5,770 receiving apixaban and 5,755 receiving enoxaparin.

“Guidelines recommend the use of anticoagulants for the prophylaxis of DVT and PE for most patients undergoing orthopedic surgery,” said Jack Lawrence, MD, vice president, development lead, Eliquis, Bristol-Myers Squibb. “I think this approval reflects the continued commitment of the alliance to deliver new treatment options for patients and physicians.”

 

According to recent data, each year in the United States an estimated 719,000 total knee-replacement surgeries and 332,000 hip-replacement surgeries are performed, and the number of hip- and knee-replacement surgeries performed each year continues to increase. The risk of DVT and PE following these surgeries remains a concern for physicians.

In December 2013, FDA accepted for review another Supplemental New Drug Application for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE.