US FDA accepts Bristol-Myers/Pfizer' Eliquis sNDA

US pharma major Bristol-Myers Squibb (NYSE: BMY) and behemoth Pfizer (NYSE: PFE) announced that the US Food and Drug Administration 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 (PDUFA) goal date for a decision by the FDA is March 15, 2014, the companies noted.

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.

Eliquis was approved for stroke prevention by the FDA on December 31, 2012 after being previously rejected by the agency earlier last year (The Pharma Letter December 31, 2012). The drug has been approved for these indications in Europe (TPL November 22, 2012) and Japan (TPL December 27, 2012).