The Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban; Janssen) for the prophylaxis of venous thromboembolism (VTE) and VTE-related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding.

The approval was based on data from the MAGELLAN and MARINER trials. In MAGELLAN, Xarelto was found to be noninferior to enoxaparin in short-term use (10±4 days) and superior in long-term use (35±4 days) vs short-term use of enoxaparin followed by placebo. However, major clinically relevant bleeding was found to be higher in the Xarelto group. In a post-hoc analysis, a favorable benefit-risk profile for VTE prevention with Xarelto was established after 5 additional exclusionary criteria removed patients at high risk for bleeding (ie, active gastroduodenal ulcer, recent bleeding, active cancer, a history of severe bronchiectasis or pulmonary cavitation, dual antiplatelet therapy at baseline).

The MARINER study evaluated Xarelto for VTE and VTE-related death prevention in medically ill adults following hospital discharge. The data showed Xarelto did not decrease the composite endpoint of VTE and VTE-related death, but was associated with a significant reduction in symptomatic VTE with consistent and favorable safety.

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“Rather than facing daily injections with older anticoagulants, patients now have a new oral treatment option that will help prevent blood clots, both in the hospital and after hospital discharge,” said James List, MD, PhD, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. With this approval, Xarelto can now be initiated in the hospital and continued after discharge for a total recommended duration of 31 to 39 days.

Xarelto, a factor Xa inhibitor, is currently indicated to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), for the reduction of the risk of recurrent DVT/PE, and for primary prevention of DVT, which may lead to PE, in patients who have just had hip or knee replacement. It is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for use in combination with aspirin, to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in patients with chronic coronary artery disease or peripheral artery disease.

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