Bristol-Myers Squibb and Pfizer announced that the FDA has approved apixaban for the prophylaxis of deep vein thrombosis in patients who have had hip or knee replacement surgery.
Apixaban (Eliquis), an oral anticoagulant, was previously approved for the prevention of stroke in patients with nonvalvular atrial fibrillation.
According to a press release, the new indication for apixaban was approved based on results from three trials from the ADVANCE clinical trial program, which randomized more than 11,000 patients to apixaban or enoxaparin to assess the safety and efficacy of apixaban.
Current guidelines recommend the use of anticoagulants for prophylaxis of DVT and pulmonary embolism for most patients after orthopedic surgery, according to the release.
“DVT, which may lead to PE, is a serious medical condition,” Richard J. Friedman, MD, FRCSC, professor of orthopedic surgery at the Medical University of South Carolina, said in the release. “The FDA approval of Eliquis gives US orthopedic surgeons a new option for DVT prophylaxis in both hip and knee replacement surgery.”
The FDA is currently reviewing another supplemental new drug application for apixaban for the treatment of DVT and PE and for the reduction of risk for recurrent DVT and PE, according to the release.