The US FDA has accepted to review Bristol-Myers Squibb Company and Pfizer's Eliquis (apixaban) supplemental new drug application for prophylaxis of deep vein thrombosis (DVT) subsequent to hip or knee replacement surgery.
The application included data from the ADVANCE-1, ADVANCE-2, and ADVANCE-3 trials, which assessed the safety and efficacy of Eliquis against enoxaparin as a part of the EXPANSE clinical trial program in approximately 12,000 patients.
Patients undergoing elective total knee replacement were evaluated in ADVANCE-1 and ADVANCE-2, while patients undergoing elective hip replacement were studied in ADVANCE-3.
Approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in the US, EU, Japan and a number of other countries around the globe, the oral direct Factor Xa inhibitor works by preventing thrombin generation and blood clot formation.
Eliquis is cleared for prevention of venous thromboembolic events (VTE) in the EU to treat adult patients who have undergone elective hip or knee replacement surgery.
