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Bayer and Johnson & Johnson are seeking a new approval for the anticoagulant Xarelto, representing a third use for the drug.
Johnson & Johnson has submitted a supplemental New Drug Application (NDA) to the US Food and Drug Administration (FDA), seeking the organisation’s approval for the drug to be administered alongside antiplatelet therapy in order to reduce the risk of thrombotic cardiovascular events in patients suffering from acute coronary syndrome.
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By GlobalDataThe submission comes after the FDA approved the use of Xarelto to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation in November 2011.
The latest NDA comes on the back of data from the Phase III Atlas ACS 2-TIMI 51 trial, which successfully demonstrated that using Xarelto in a 2.5mg dosage twice a day alongside standard antiplatelet therapy greatly reduced the likelihood of cardiovascular death, myocardial infarcation or stroke in patients who had suffered from a recent bout of acute coronary syndrome.
The combination also reduced the rate of cardiovascular death and the incidence of mortality by more than 30% when compared with antiplatelet therapy alone.
Xarelto was originally approved in the US in July 2011 for the prevention of venous thromboembolism following hip or knee replacement surgery.