Bristol-Myers Squibb (BM-S) and Pfizer have announced the UK launch of Eliquis (apixaban), an oral treatment for the prevention of venous thromboembolic events (VTE) in adult patients who have had elective total hip or knee replacement surgery.
"VTE is responsible for around 25,000 preventable deaths in the UK annually, and preventing them following for example major joint surgery is a priority for the NHS. Apixaban represents a new option in clot prevention for UK surgeons," said Dr Ander Cohen, honorary consultant vascular physician at King's College Hospital, London.
"Apixaban provides oral administration to suit patients once they return home after surgery, during the time when they are most at risk of clotting complications," he added.
Lead investigator for the Phase III orthopaedic trials for apixaban is Professor Michael Rud Lassen of the Glostrup Hospital in Copenhagen, Denmark, who commented: "the initiation of treatment after surgery is an option recommended in guidelines. Doctors have to consider the benefits of treatment before or after surgery against the risk of bleeding, which can be caused by anticoagulation. The first dose of apixaban is given 12-24 hours after surgery, which allows the doctor time to ensure bleeding has stopped."
The product's licensing is based on the ADVANCE-2 and ADVANCE-3 clinical trials, in which apixaban given orally twice-daily demonstrated superior efficacy versus enoxaparin 40mg given once-daily by injection in the prevention of VTE in elective total knee and total hip replacement, and did not increase the risk of bleeding versus enoxaparin.
The ADVANCE-2 and ADVANCE-3 trials randomised over 8,000 patients and assessed the efficacy and bleeding risk of apixaban compared to enoxaparin. The primary efficacy endpoint of ADVANCE-2 and ADVANCE-3, which studied patients undergoing elective total knee or hip replacement, respectively, was defined as the composite of asymptomatic and symptomatic deep vein thrombosis (DVT), nonfatal pulmonary embolism (PE) and death from any cause during study treatment. The principal safety measure in the trials was the composite of major and clinically-relevant non-major bleeding.
In 2007, Pfizer and BM-S entered into a worldwide collaboration to develop and commercialise apixaban, an investigational oral anticoagulant which was discovered by BM-S.
Making the product available to healthcare providers and their patients in the UK is "an important milestone" for the alliance of BM-S and Pfizer, and by doing so "we hope to help reduce the burden of thrombotic disorders in patients undergoing elective total hip and knee replacement," said Dr Rick Lones, UK executive medical director at BM-S.