The European Commission has approved apixaban (Eliquis) in the 27 countries of the European Union (EU) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. This decision marks the first approval for apixaban, a new oral direct Factor Xa inhibitor being developed by the alliance of Bristol-Myers Squibb and Pfizer.
Apixaban is an oral anticoagulant with a 12- to 24-hour post surgery initiation window, which may help physicians to observe and stabilize post-surgical patients before beginning treatment, according to the companies. Apixaban is dosed 2.5 mg twice daily, requires neither routine platelet or liver monitoring nor dose adjustment in indicated patients. In patients undergoing hip replacement surgery, the recommended duration of treatment is 32 to 38 days. In patients undergoing knee replacement surgery, the recommended duration of treatment is 10 to 14 days.
The approval of apixaban is based on the ADVANCE-2 and ADVANCE-3 trials, part of the EXPANSE program. In these trials, apixaban was given orally twice daily, compared with 40 mg of enoxaparin (Lovenox, Sanofi-Aventis), which was given once daily by injection to prevent VTE in total knee and total hip replacement, according to BMS and Pfizer. The trials randomized more than 8,000 patients and assessed the safety and efficacy of apixaban compared to enoxaparin.
In March, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended granting of a marketing authorization for the 2.5 mg film-coated tablet.