Rivaroxaban achieved superior efficacy in the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement surgery in a head-to-head comparison with Sanofi-Aventis’ Lovenox, known generically as enoxaparin, the current standard of care.
Patients treated with rivaroxaban demonstrated a 49% relative risk reduction in the composite primary endpoint of deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE) and all-cause mortality compared to those treated with enoxaparin.
A 62% reduction of risk for developing major VTE (the composite of proximal DVT, non-fatal PE and VTE-related death) – the secondary endpoint of the trial – was observed in the patients treated with rivaroxaban. Rivaroxaban also demonstrated a similarly low rate of major bleeding compared to enoxaparin (0.6% and 0.5%, respectively).
Rivaroxaban is an investigational, oral, once-daily direct factor Xa inhibitor. It is an anticoagulant – a drug designed to prevent and treat blood clots – in advanced clinical development for the prevention and treatment of thrombosis in acute and chronic settings.
The drug is being jointly developed by Johnson & Johnson Pharmaceutical R&D, and Bayer HealthCare AG.
The companies plan to submit regulatory filings for the prevention of VTE in orthopaedic surgery in late 2007 in Europe and in 2008 in the US.