Bayer has submitted its oral anticoagulant Xarelto (rivaroxaban) to the European Medicines Agency for marketing authorisation for secondary prevention, after onset, of acute coronary syndrome (ACS).
The submission is based on clinical trial results that indicated a 34% relative risk reduction in cardiovascular mortality when the drug is used in combination with antiplatelet therapy.
Xarelto is the first oral direct factor Xa inhibitor, acting at a specific point in the clot formation process, and is the first anticoagulant other than vitamin K antagonists to be submitted in this indication.
ACS is the blocking of a coronary artery by a blood clot, and occurs as a complication of coronary heart disease. It can directly cause heart attack or unstable angina.
The global phase III ATLAS ACS 2-TIMI 51 study showed that adding twice-daily rivaroxaban to standard antiplatelet therapy reduced the incidence of cardiovascular death after a recent ACS by 34%.
The combination also reduced the incidence of stent thrombosis relative to standard therapy. It increased the incidence of major bleeding events, but not of fatal bleeding.
“The prevention of subsequent ACS episodes is a critically important clinical target and in rivaroxaban, we have a compound which offers a significant reduction in both CV death and all-cause mortality,” said Luis-Felipe Graterol, Medical Director, Bayer Healthcare UK.
Xarelto is currently approved in the UK for prevention of venous thromboembolism (VTE) after hip or knee replacement surgery; prevention of stroke in patients with non-valvular atrial fibrillation; and secondary treatment of deep vein thrombosis (DVT).
Rivaroxaban was discovered by Bayer Healthcare in Germany and is being jointly developed by Bayer and Janssen (a Johnson & Johnson company), who co-funded the ATLAS ACS 2-TIMI 51 study. The drug is marketed in the US by Janssen.