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Published on 9 January 2012

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Approval sought for acute coronary syndrome drug

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Bayer HealthCare has submitted an application for marketing authorisation to the European Medicines Agency (EMA) for the oral anticoagulant Xarelto® (rivaroxaban) in combination with standard antiplatelet therapy for secondary prevention after an Acute Coronary Syndrome (ACS).

Results from the pivotal, global Phase III ATLAS ACS 2-TIMI 51 study, published by the New England Journal of Medicine, showed that the combination of oral rivaroxaban 2.5 mg twice-daily with 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 receiving standard antiplatelet therapy alone.

In addition, rivaroxaban 2.5 mg twice-daily in combination with standard therapy significantly reduced both the relative rate of cardiovascular death by 34% (ARR 1.4 %) and the incidence of all-cause mortality by 32% (ARR 1.6 %) over standard therapy alone.

There was also a significant reduction in the incidence of stent thrombosis which can often have fatal consequences.

The study also showed that the regimen of 2.5 mg twice-daily rivaroxaban in combination with standard antiplatelet therapy exhibited a higher rate of TIMI major bleeding events not associated with coronary artery bypass graft (CABG) surgery, but importantly did not increase the risk of fatal bleeding over standard therapy alone.

Rivaroxaban is currently approved in the UK in three indications: VTE prevention in adult patients following elective hip or knee replacement surgery; the prevention of stroke and non-CNS systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors; and the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.

New England Journal of Medicine


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