CHMP recommends Xarelto (Bayer) for prevention of atherosclerotic events after ACS
The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bayer HealthCare's oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice-daily in combination with standard antiplatelet therapy for the prevention of atherothrombotic events (myocardial infarction, cardiovascular death or stroke) after an Acute Coronary Syndrome (ACS) in adult patients with elevated cardiac biomarkers. Elevated cardiac biomarkers confirm the ACS and characterize patients at high risk of recurrent events.
The final decision of the European Commission on the approval is expected in the first half of this year.
Data from the pivotal Phase III ATLAS ACS 2-TIMI 51 study of more than 15,500 patients demonstrated that the addition of rivaroxaban 2.5 mg BID to standard antiplatelet therapy significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction or stroke in patients after a recent ACS compared to those who received standard antiplatelet therapy alone.
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