BMS/Pfizer file Eliquis as a prophylaxis treatment for DVT

BMS/Pfizer announced on 11 July 2013, that the FDA has accepted for review a Supplemental New Drug Application (sNDA) for Eliquis (apixaban), for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. The Prescription Drug User Fee Act goal date for a decision by the FDA is March 15, 2014.

The submission is 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.