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FDA Grants Priority Review to Rivaroxaban (Xarelto) for ACS Patients
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...
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Decision on Apixaban (Eliquis) Pushed Back By Three Months
Update, March 1, 5 PM: Ramsay Baghadi of the RPM Report says that the Cardiorenal committee will take up the apixaban NDA on Mary 22 and the rivaroxaban supplemental NDA for the ACS indication on May...
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And the 2012 Award For the Most Dumbass Drug Promotion Goes To…
The year 2012 is only 25% complete but it's never too early to recognize an unprecedented and bold achievement in drug marketing. More…
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Rivaroxaban For ACS Gets Positive FDA Review, But Questions About ATLAS Trial...
The FDA will offer generally positive but also highly mixed advice to the FDA’s Cardiovascular and Renal Drugs Advisory Committee when it meets on Wednesday to consider the supplemental new drug...
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Live Blog: The FDA Advisory Panel For Rixaroxaban for ACS
Here’s my live-blogg of the FDA’s Cardiovascular and Renal Drugs Advisory Committee meeting to consider the supplemental new drug application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for...
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FDA Advisory Committee Recommends Against ACS Indication For Rivaroxaban
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against adding an indication for acute coronary syndromes (ACS) to the label of the anticoagulant rivaroxaban (Xarelto). The vote was...
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FDA Rejects ACS Indication for Rivaroxaban (Xarelto)
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...
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Setback For Trial Studying Dabigatran After Mechanical Valve Surgery
Despite the recent advent of novel oral anticoagulants, the much-maligned warfarin remains the only current option available for patients who have received a mechanical valve. Now the first trial to...
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Rivaroxaban Gains FDA Indications For The Treatment And Prevention Of DVT And PE
The FDA today 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 of...
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Boehringer Ends Phase 2 Trial Of Dabigatran In Mechanical Valve Patients
Boehringer Ingelheim today announced that it had discontinued a phase 2 trial of its anticoagulant drug dabigatran (Pradaxa) in patients with mechanical heart valves. As reported here in October, the...
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Two Experts Help Sort Out The New Generation Of Anticoagulants
Don’t miss this very practical discussion about the new generation of anticoagulants over on CardioExchange. Here are a few excerpts. Christian Thomas Ruff: I believe the addition of the 3 currently...
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FDA Again Rejects ACS Indication for Rivaroxaban (Xarelto)
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...
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Rivaroxaban Gains Approval In Europe For ACS Indication
Rivaroxaban (Xarelto, Bayer) has been approved in Europe for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) following an acute coronary syndrome...
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Possible New Lease On Life For Two Cardiology Drugs From Merck And J&J
Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a...
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FDA Panel Once Again Rejects New Indication For Rivaroxaban
The FDA’s Cardiovascular and Renal Drugs Advisory Committee once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto...
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Boehringer Ingelheim’s Pradaxa Gains New Indication
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...
View ArticleNew Questions Raised About ROCKET AF, Pivotal Xarelto Trial Chaired By Califf
(Updated) Disturbing questions are being raised about the integrity and reliability of crucial data in the ROCKET AF trial. The investigation could have important implications on several fronts. First,...
View ArticleROCKET-AF Investigators Seek To Calm Concerns About Trial Reliability
(Updated) In response to disturbing questions about the integrity and reliability of crucial data in the ROCKET AF trial, the executive committee of the trial has released a statement saying that they...
View ArticleNew Studies Seek To Allay Concerns Over The ROCKET-AF Trial
New post-hoc analyses of ROCKET-AF confirm the main results of the controversial trial, according to a paper published in the New England Journal of Medicine. The papers are a response to disturbing...
View ArticleROCKET AF Investigators Say New Analysis Supports Original Trial Results
–Test of stored blood may help answer troubling questions about the trial. A new analysis of stored blood by the ROCKET AF trial investigators may help resolve lingering questions about the trial. The...
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