Bayer's Xarelto Approved in the EU for Secondary Prevention After ACS

May 24, 2013—Bayer AG (Leverkusen, Germany) announced that its oral anticoagulant Xarelto (rivaroxaban) has been approved in Europe for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction, or stroke) after an acute coronary syndrome (ACS) in adult patients with elevated cardiac biomarkers at a dose of 2.5 mg twice-daily (BID) in combination with standard antiplatelet therapy. Rivaroxaban targets Factor Xa, a key trigger of thrombin generation, noted the company.

Michael Gibson, MD, who is Chairman of the PERFUSE Study Group, Harvard Medical School, and the Principal Investigator in the ATLAS ACS studies, commented in the company's press release, 
“We know that thrombin levels remain elevated long after an ACS event, leaving patients at risk. In the ATLAS ACS 2-TIMI 51 study, we've shown that treating these patients with a low dose of rivaroxaban in combination with standard antiplatelet therapy targets both pathways of clot formation providing more complete long-term protection, including significant reduction in mortality risk. This approval marks an important shift in the way we deliver protection to patients who are at risk of a secondary atherothrombotic event.”



The company advised that the approval of rivaroxaban in this indication is based on clinical findings of the pivotal phase III ATLAS ACS 2-TIMI 51 study of more than 15,500 patients. The study demonstrated that the addition of rivaroxaban 2.5 mg BID to standard antiplatelet therapy—low-dose aspirin with or without a thienopyridine (clopidogrel or ticlopidine)—significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction, or stroke in patients after recent ACS compared to those who received standard antiplatelet therapy alone. The rate of TIMI (thrombolysis in myocardial infarction) major bleeding events not associated with coronary artery bypass graft (CABG) surgery and the rate of intracranial hemorrhage were low overall, yet increased with the addition of rivaroxaban. There was no increase observed with rivaroxaban in the risk of fatal intracranial hemorrhage or fatal bleeding, noted Bayer.