The approval is based on the ADVANCE-2 and ADVANCE-3 clinical trials, part of the EXPANSE clinical trial program.
ELIQUIS is an oral anticoagulant with a 12- to 24-hour post surgery initiation window, which aids physicians to monitor and stabilize post-surgical patients before beginning treatment.
In these trials, ELIQUIS given orally twice daily demonstrated efficacy versus enoxaparin 40 mg given once daily by injection in the prevention of VTE in total knee and total hip replacement, and did not increase the risk of bleeding versus enoxaparin.
ELIQUIS Phase 3 orthopedic trials lead investigator Michael Rud Lassen said the approval of ELIQUIS gives European orthopedic surgeons a new option in VTE prevention that is effective than the current standard of care, enoxaparin 40 mg once daily, and importantly, without increasing bleeding.