The FDA will review a Supplemental New Drug Application for the anticoagulant apixaban for the prevention of deep vein thrombosis in adults who undergo hip or knee replacement surgery.
The FDA approved apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) in late 2012 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation after a lengthy approval process. A recent review of FDA documents attributed the delay to fraud and dispensing errors during the trial.
Patients who undergo total knee or total hip replacement are at risk of deep vein thrombosis, which can progress to pulmonary embolism. Apixaban, an oral direct Factor Xa inhibitor, was approved for this indication by the Europe Commission in 2011 based on the ADVANCE-2 and ADVANCE-3 trials, part of the EXPANSE program.
The FDA will review data from these trials with a goal date for a decision of March 15, 2014.