This week’s topics include extended use of apixaban, dabigatran, warfarin, or placebo in VTE, the 5-year follow-up of the SYNTAX study, and more.
Three studies published in the New England Journal of Medicine provide important new information about the risks and benefits of extended prophylaxis using two of the new oral anticoagulants in patients who have had venous thromboembolism (VTE). In the RE-MEDY and the RE-SONATE trials, the role of dabigatran was examined in patients who had completed at least 3…
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Two experts discuss the evolving landscape of novel anticoagulants for patients with AF. Do you agree with their perspectives? What questions do you have? What has your experience taught you?
The FDA has finally approved apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). The action comes after the widely-anticipated drug had been plagued by delays at the FDA but well before the PDUFA deadline of March 17, 2013. Eliquis is the latest member…
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John Ryan reviews the latest data and suggests that DVT/PE be managed as a chronic condition. Are you using apixaban in these patients, and how long are you treating them for?
A new study suggests that extending anticoagulant therapy for an additional year may be beneficial after patients with venous thromboembolism complete their initial course of therapy. The results of AMPLIFY-EXT (Apixaban after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy-Extended Treatment) were presented at the annual meeting of the American Society…
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The FDA will decide the fate of apixaban (Eliquis) by March 17, 2013. The new Prescription Drug User Fee Act (PDUFA) goal date was announced yesterday by the drug’s manufacturers, Pfizer and Bristol-Myers Squibb. The new drug application (NDA) for apixaban for stroke prevention in atrial fibrillation has been delayed twice. Although the pivotal ARISTOTLE trial was highly…
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The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval for apixaban (Eliquis, Pfizer and BristolMyers Squibb) for atrial fibrillation. The drug is already approved in Europe for the prevention of venous thromboembolic events following hip or knee replacement surgery. The drug has not yet been approved in the United States. Here is the CHMP-proposed indication…
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The FDA has once again delayed approval of apixaban (Eliquis), the much-anticipated oral anticoagulant. Bristol-Myers Squibb and Pfizer announced today that it had received a a Complete Response Letter (CRL) to the New Drug Application (NDA) for the drug for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The two companies reported…
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McMaster University’s Salim Yusuf has tied for second place in the annual ranking of the “hottest” scientific researchers, according to Thomson Reuter’s Science Watch. Yusuf was a co-author of 13 of the most cited papers in 2011. Only one other researcher, genomic pioneer Eric Lander of the Broad Institute of MIT and Harvard, had more highly-cited papers than Yusuf. Two…
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