Bayer HealthCare submits Rivaroxaban for European approval

Bayer HealthCare has submitted a Marketing Authorisation Application to the European Agency for the Evaluation of Medicinal Products (EMEA) for approval to market rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) after major orthopedic surgery of the lower limbs.

Rivaroxaban is an investigational, oral, once-daily direct Factor Xa inhibitor. Data from one of the pivotal studies was presented prior to the EMEA submission and revealed that rivaroxaban significantly reduces the risk of VTE in patients undergoing total knee replacement surgery compared with enoxaparin, the current standard of care therapy.

Rivaroxaban is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development.

VTE is a thromboembolic disease caused by the obstruction of a blood vessel by a blood clot. In the EU it is estimated that there are 543,000 deaths due to VTE each year. People undergoing major surgery, in particular total knee or hip replacement, are prone to developing VTE due to a combination of factors such as prolonged bed rest, damage to blood vessels and an increased tendency of the blood to clot. It is estimated that up to 50% of patients undergoing lower limb surgery develop VTE if they do not receive preventative care.

Upon regulatory approval, rivaroxaban will be commercialised in Europe by Bayer Schering Pharma. A filing for rivaroxaban for a similar indication in the US is planned in 2008, where if approved, it will be will commercialised by Scios Inc and Ortho-McNeil, Inc, both of which are Johnson & Johnson companies.