Eliquis has been approved in the EU for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
The decision is based on the results from the ADVANCE-2 and ADVANCE-3 clinical trials which demonstrated that oral doses of Eliquis were superior versus a once-daily enoxaparin injection.
Michael Rud Lassen, Glostrup Hospital, Copenhagen, Denmark, and lead investigator for the Phase III trials, says the direct Factor Xa inhibitor is “more effective than the current standard of care”.
The drug is also being investigated in Phase III trials for the treatment of VTE, the prevention of VTE in hospitalised acutely ill patients, and the prevention of stroke and other thromboembolic events in patients with atrial fibrillation.
Eliquis is the only oral anticoagulant with a 12- to 24-hour post surgery initiation window, which may help physicians to observe and stabilise patients after surgery before beginning treatment.
“The approval of Eliquis provides a new oral option for patients in the EU undergoing elective hip or knee replacement surgery, where the risk of bleeding is a significant concern,” said Olivier Brandicourt, President and General Manager, Primary Care, Pfizer.
“We are excited to bring this new agent to market in Europe and provide orthopaedic surgeons with an option that will help them to prevent VTE in patients undergoing elective total knee or total hip replacement surgery.”
Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialise Eliquis in 2007.