I’m not a doctor but I thought I knew something about anticoagulation. Over the course of a career covering cardiology I’ve written countless stories about heparin, warfarin, the low molecular weight heparins, and the new oral anticoagulants. So when I had bilateral total knee replacement a few weeks ago I thought I knew what to…
In Which I Go Under The Knife And Learn About Medicine In The Real World
January 27, 2017 by 7 Comments
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…
FDA Reaffirms Safety And Efficacy Of Rivaroxaban
October 11, 2016 by Leave a Comment
–FDA says no changes needed to the rivaroxaban label. Following a year of controversy and uncertainty relating to the anticoagulant drug rivaroxaban (Xarelto, Johnson & Johnson), the FDA has reaffirmed the drug’s safety and efficacy. Rivaroxaban is approved for stroke reduction in patients with atrial fibrillation. The indication is based on results of the ROCKET-AF…
More Bleeding Linked To Rivaroxaban In Observational Study
October 4, 2016 by 1 Comment
–Compared to dabigatran, rivaroxaban was associated with more intracranial and other serious bleeds. A new observational study finds that patients who take rivaroxaban (Xarelto, Johnson & Johnson) may be more likely to have serious bleeding events than patients who take dabigatran (Pradaxa, Boehringer Ingelheim). In a paper published in JAMA Internal Medicine, David Graham and…
More Blasts Of Concern Over ROCKET-AF
September 28, 2016 by 1 Comment
The controversy over the big Xarelto trial does not appear to be going away. A new investigation published in the BMJ raises more troubling questions about the ROCKET-AF trial, which compared the novel oral anticoagulant rivaroxaban (Xarelto, Johnson & Johnson) to warfarin in patients with atrial fibrillation. The controversy about the trial first unfolded last…
ROCKET AF Investigators Say New Analysis Supports Original Trial Results
July 6, 2016 by 1 Comment
–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 questions about ROCKET AF, which compared rivaroxaban (Xarelto, Johnson & Johnson) to warfarin in patients with atrial fibrillation, emerged last November, when…
New Studies Seek To Allay Concerns Over The ROCKET-AF Trial
February 3, 2016 by Leave a Comment
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 questions about the trial raised last fall. But the new analyses will not fully satisfy some critics of the trial who are calling for…
ROCKET-AF Investigators Seek To Calm Concerns About Trial Reliability
December 13, 2015 by Leave a Comment
(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 have “conducted a secondary analysis of the trial findings” and that “the findings from the analysis are consistent with the results from the original trial and do not…
New Questions Raised About ROCKET AF, Pivotal Xarelto Trial Chaired By Califf
November 30, 2015 by 1 Comment
(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, the trial serves as the basis for the use of the blockbuster drug rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in atrial fibrillation. Second, the…
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. …
FDA Panel Once Again Rejects New Indication For Rivaroxaban
January 16, 2014 by Leave a Comment
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 (rivaroxaban). The nearly unanimous vote (10-0, with 1 abstention) was in line with a highly negative review from FDA staff members. … Click here to read the full post on Forbes….
Possible New Lease On Life For Two Cardiology Drugs From Merck And J&J
December 16, 2013 by Leave a Comment
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 rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and Renal…
Rivaroxaban Gains Approval In Europe For ACS Indication
May 24, 2013 by Leave a Comment
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 (ACS). The drug was approved at a dose of 2.5 mg twice-daily and should be used in combination with standard antiplatelet therapy. Rivaroxaban is now the only oral anticoagulant to receive an…
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…
Two Experts Help Sort Out The New Generation Of Anticoagulants
January 17, 2013 by Leave a Comment
Don’t miss this very practical discussion about the new generation of anticoagulants and the short term loan costs to cover them over on CardioExchange. Here are a few excerpts. Christian Thomas Ruff: I believe the addition of the 3 currently approved novel anticoagulants (dabigatran, rivaroxaban, and apixaban) will eventually translate into a greater proportion of eligible patients…
Boehringer Ends Phase 2 Trial Of Dabigatran In Mechanical Valve Patients
December 12, 2012 by 2 Comments
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 company had previously terminated one arm of the study after an interim review of the data by the trial’s Data Safety Monitoring Board The RE-ALIGN trial was an open-label,…
Rivaroxaban Gains FDA Indications For The Treatment And Prevention Of DVT And PE
November 2, 2012 by Leave a Comment
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 recurrent DVT and PE. The oral anticoagulant is already approved to reduce the post-surgical risk of DVT and PE after hip and knee replacement…
Setback For Trial Studying Dabigatran After Mechanical Valve Surgery
October 23, 2012 by 2 Comments
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 explore this indication for a newer oral anticoagulant has suffered a setback. Last year Boehringer Ingelheim announced the launch of the RE-ALIGN trial, a phase…
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 Advisory Committee Recommends Against ACS Indication For Rivaroxaban
May 23, 2012 by 1 Comment
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 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 2-TIMI…
Live Blog: The FDA Advisory Panel For Rixaroxaban for ACS
May 23, 2012 by 1 Comment
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 use in patients with acute coronary syndrome (ACS) already taking dual antiplatelet therapy. Here is a link to the FDA briefing documents. ========================= 4:48: Meeting adjourned! J&J has just issued a press release…
Rivaroxaban For ACS Gets Positive FDA Review, But Questions About ATLAS Trial Conduct Persist
May 21, 2012 by 2 Comments
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 application for rivaroxaban (Xarelto, Johnson & Johnson) for use in patients with acute coronary syndrome (ACS) already taking dual antiplatelet therapy. The FDA posted the briefing documents…
And the 2012 Award For the Most Dumbass Drug Promotion Goes To…
March 29, 2012 by 7 Comments
The year 2012 is only 25% complete but it’s never too early to recognize an unprecedented and bold achievement in drug marketing. …
Decision on Apixaban (Eliquis) Pushed Back By Three Months
February 29, 2012 by 1 Comment
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 23, but this information has not been confirmed. Confirming earlier speculation by a Wall Street analyst, Pfizer and Bristol-Myers…
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…
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