Bristol-Myers Squibb and Pfizer announced that the FDA has accepted for review a supplemental New Drug Application (sNDA) for Eliquis (apixaban), for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in adult patients who have undergone hip or knee replacement surgery. Eliquis is an oral direct Factor Xa inhibitor that prevents thrombin generation and blood clot formation.
The submission was supported by the ADVANCE-1, ADVANCE-2, and ADVANCE-3 clinical trials, part of the EXPANSE clinical trial program. These trials randomized nearly 12,000 patients and assessed the safety and efficacy of Eliquis compared to enoxaparin. ADVANCE-1 and ADVANCE-2 studied patients undergoing elective total knee replacement, and ADVANCE-3 studied patients undergoing elective hip replacement.
Eliquis is already approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
For more information call (855) 354-7847 or visit www.eliquis.com.