The recent arrival of novel oral anticoagulants has provided important new options for treating and preventing venous thromboembolism (VTE). New indications for these drugs have been granted for patients with atrial fibrillation and for patients who have undergone orthopedic surgery. But an additional indication, for acutely ill medical patients at risk for VTE, does not…

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The FDA has expanded the indication for rivaroxaban (Xarelto, Johnson & Johnson) to include the treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk for recurrent DVT and PE. The oral anticoagulant is already approved to reduce postsurgical risk for DVT and PE  after hip- and knee-replacement surgery and to…

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The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted today against adding an indication for acute coronary syndromes (ACS) to the label of the anticoagulant rivaroxaban (Xarelto). The vote was 6 to 4 against approval, with 1 abstention. The advisory panel spent most of the day trying to reconcile diametrically opposed views of the pivotal ATLAS ACS…

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Confirming earlier speculation by a Wall Street analyst, Pfizer and Bristol-Myers Squibb announced on Wednesday evening that the FDA had extended by 3 months the action date for the new drug application (NDA) for the highly anticipated oral anticoagulant apixaban (Eliquis). The application is for their important indication of stroke prevention in atrial fibrillation. The…

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The FDA has granted a priority review for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) in combination with standard therapy to reduce the risk for cardiovascular events in acute coronary syndrome (ACS) patients. The news was announced by Bayer and Johnson & Johnson. The FDA will now be required to respond within 6 months, instead of…

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Based on the promising results of the recently published ATLAS ACS 2 TIMI 51 trial, Johnson & Johnson has submitted a supplemental new drug application to the FDA for the approval of rivaroxaban (Xarelto) to reduce the risk of thrombotic cardiovascular events in ACS patients. Following a succession of failed trials, ATLAS was the first trial…

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The FDA has approved rivaroxaban (Xarelto, Johnson & Johnson) for stroke reduction in people with non-valvular atrial fibrillation. The label will include a boxed warning that people should not discontinue taking the drug without talking with a healthcare professional. The FDA will also require that patients getting the drug receive a Medication Guide describing the…

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The European Committee for Medicinal Products for Human Use (CHMP) has recommended that rivaroxaban (Xarelto) be approved for the prevention of stroke and systemic embolism in AF, according to Bayer HealthCare. CHMP has also recommended the drug’s approval for the treatment of DVT and for the prevention of recurrent DVT and PE following acute DVT….

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