EU approves Xarelto (Bayer) for Acute Coronary Syndrome
The EU has approved the use of Xarelto (rivaroxaban), from Bayer, to prevent cardiovascular events in patients with Acute Coronary Syndrome (ACS). The approval was based on data from the ATLAS ACS study.
The ATLAS ACS study involved more than 15,500 patients and demonstrated that adding a 2.5mg dose of Xarelto to standard antiplatelet therapy significantly reduced cardiovascular death, myocardial infarction or stroke in patients after a recent ACS event, compared to those who received standard therapy alone. In March 2013, the FDA rejected an NDA for Xarelto for use with ACS.
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