–Observational study compares new anticoagulants to warfarin in VTE population. In clinical trials the new oral anticoagulants (NOACs) have been shown to have similar efficacy and safety compared to warfarin, but questions have been raised about whether the results are similar in real world settings. Now a new observational study lends some measure of reassurance…
Eliquis Nipping At The Heels of NOAC Market Leader Xarelto
October 20, 2016 by 1 Comment
–But the overall market for the new oral anticoagulants continues to expand. The new oral anticoagulant (NOAC) market is growing larger and is becoming increasingly competitive. The latest market data shows that apixaban (Eliquis, Pfizer and BristolMyers Squibb) is challenging the established leader in the field, rivaroxaban (Xarelto, Johnson & Johnson). According to recent data…
Boehringer Ingelheim’s Pradaxa Gains New Indication
April 7, 2014 by 1 Comment
The new oral anticoagulants continue to gain additional indications from the FDA. Earlier today Boehringer Ingelheim announced that the FDA had approved Pradaxa (dabigatran) for the treatment of venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE). … Click here to read the full post on Forbes. …
Apixaban Gains Indication For DVT Prophylaxis After Knee And Hip Replacement Surgery
March 14, 2014 by Leave a Comment
The FDA has approved a new indication for apixaban (Eliquis), the anticoagulant drug manufactured by Bristol-Myers Squibb and Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) in patients who have undergone hip or knee replacement surgery. DVT can lead to the life-threatening condition of pulmonary embolism (PE). The DVT prophylaxis indication joins the previously…
Problems Persist Despite Gains In Oral Anticoagulant Use
January 28, 2014 by Leave a Comment
Although significant progress has been made in recent years, a new survey from the European Society of Cardiology finds that there are still too many atrial fibrillation patients who are not taking the best medications to reduce their elevated risk of stroke. Many elderly patients are not receiving oral anticoagulants and overall too many patients…
FDA Again Rejects ACS Indication for Rivaroxaban (Xarelto)
March 4, 2013 by Leave a Comment
For the second time the FDA has turned down the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) to treat patients with acute coronary syndrome (ACS). … In a new press release issues on Monday afternoon, the company restated its confidence “in the robustness and results of the ATLAS…
Longer Warfarin Therapy After Bioprosthetic Aortic Valve Replacement May Be Beneficial
November 27, 2012 by Leave a Comment
Three months of warfarin is the usual standard of care following bioprosthetic aortic valve replacement (AVR), although the supporting evidence base for this practice is limited. Now a large new registry study published in JAMA suggests that more prolonged warfarin therapy may be beneficial. Danish researchers identified 4,075 patients who underwent bioprosthetic AVR. As expected,…
Apixaban (Eliquis) For Atrial Fibrillation Gets Positive European Recommendation
September 21, 2012 by 2 Comments
The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval for apixaban (Eliquis, Pfizer and BristolMyers Squibb) for atrial fibrillation (AF). The drug is already approved in Europe for the prevention of venous thromboembolic events (VTE) following hip or knee replacement surgery. The drug has not yet been approved in the United States. Here…
FDA Once Again Delays Approval Of Apixaban (Eliquis)
June 25, 2012 by 2 Comments
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…
FDA Rejects ACS Indication for Rivaroxaban (Xarelto)
June 21, 2012 by 2 Comments
The FDA has issued a complete response letter to the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) in patients with acute coronary syndrome (ACS). The action was expected, since last month the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against recommending the new indication, which was based on…
FDA Grants Priority Review to Rivaroxaban (Xarelto) for ACS Patients
February 28, 2012 by Leave a Comment
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 of 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…
Guest Post: Industry Sponsored Editorial Assistance
February 12, 2012 by 4 Comments
Editor’s Note: The following guest post by Tom Yates is reprinted with permission from his blog Sick Populations. Yates is a UK-based physician with an interest in epidemiology and population health. Industry Sponsored Editorial Assistance by Tom Yates The September 2011 edition of the Quarterly Journal of Medicine contained two review articles which dealt with the use…
Study Explores Role of Periprocedural Dabigatran in AF Ablation
February 2, 2012 by 1 Comment
Updated with a comment from John Mandrola– As dabigatran becomes more widely used in atrial fibrillation (AF) patients, electrophysiologists are now trying to figure out how to handle anticoagulation in patients taking dabigatran (Pradaxa) for whom AF ablation is planned. In a new study published in the Journal of the American College of Cardiology, Dhanunjaya Lakkireddy and colleagues…
Recent Comments