FDA approves new indication for apixaban

The FDA has approved a supplemental New Drug Application for the anticoagulant apixaban for the prevention of deep vein thrombosis, which may lead to pulmonary embolism in patients who have undergone hip or knee replacement surgery.

Apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) was approved for this indication by the Europe Commission in 2011 based on the ADVANCE-2 and ADVANCE-3 trials. The FDA also based its decision on ADVANCE data, according to the companies.

The FDA previously approved apixaban, an oral direct Factor Xa inhibitor, in late 2012 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.