Apixaban Gains Indication For DVT Prophylaxis After Knee And Hip Replacement Surgery

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…

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FDA Once Again Rejects New Indication For Rivaroxaban

The third time wasn’t the charm. The FDA today turned turned down– for the third time– the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke or death. In addition, the FDA– for the second time– turned down the sNDA for rivaroxaban in…

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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 (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….

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Rivaroxaban Faces Uphill Battle At FDA Advisory Panel

The third time may not be the charm. Twice before the FDA has turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (rivaroxaban). On Thursday the Cardiovascular and Renal Drugs Advisory Committee will take up the sNDA yet again, but FDA review documents posted today suggest that the company will again…

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New Trial Confirms Role For Pradaxa In Venous Thromboembolism

Pradaxa

A new study helps support a role for  the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in patients with venous thrombosis (VTE).  The RE-COVER II trial, published online in Circulation, confirms the finding of the earlier and highly similar RE-COVER trial, published in the New England Journal of Medicine in 2009, that dabigatran is as safe and effective as warfarin for…

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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 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…

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Large Study Finds Favorable Risk-Benefit Profile For The New Anticoagulants

A very large new meta-analysis finds a favorable risk-benefit for the new oral anticoagulant drugs in the setting of atrial fibrillation. The findings, published online in the Lancet, were remarkably consistent for all four of the new agents which have been fighting to replace warfarin, which was the only oral anticoagulant available for decades until the arrival of…

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FDA Turns Back New Indication For Rivaroxaban To Prevent Stent Thrombosis In ACS Patients

Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application for rivaroxaban (Xarrelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the  general use of rivaroxaban to…

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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 (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…

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CHMP And FDA Diverge On Mipomersen And Rivaroxaban

The US FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected— for the second time– an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the…

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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 syndrome (ACS). … In a new press release issues on Monday afternoon, the company restated its confidence “in the robustness and results of the ATLAS…

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New Studies Examine Prolonged Anticoagulation For VTE Recurrence

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 an accompanying editorial, Jean Connors writes that “deciding how to balance the risks and benefits of extended anticoagulation is…

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Rivaroxaban Effective In Medically Ill Patients But At High Bleeding Cost

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

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FDA Approves Eliquis (Apixaban) For Stroke Prevention In AF

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. 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…

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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 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,…

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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 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…

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High Rate Of Warfarin Discontinuation Observed In Study

One of the many potential problems with warfarin-based anticoagulant therapy is the poor rate of adherence and persistence among patients who are prescribed the drug. Now a new observational study published in Archives of Internal Medicine raises the possibility that the problem may be even worse than many may have previously suspected, as discontinuation rates in clinical…

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News Briefs: Cholesterol Trends, AHA Late-Breakers, FDA Updates On Rivaroxaban And Heartware HVAD

Cholesterol Trends The Centers for Disease Control issued a new report with the latest details about the prevalence of cholesterol screening and high blood cholesterol in US adults. Here is their summary of the key findings: …cholesterol screening increased from 72.7% in 2005 to 76.0% in 2009, whereas the percentage of those screened who reported…

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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 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…

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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 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…

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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 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…

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Rivaroxaban For ACS Gets Positive FDA Review, But Questions About ATLAS Trial Conduct Persist

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…

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And the 2012 Award For the Most Dumbass Drug Promotion Goes To…

Xarelto 2011 Drug of the Year

The year 2012 is only 25% complete but it’s never too early to recognize an unprecedented and bold achievement in drug marketing. …

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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 23, but this information has not been confirmed. Confirming earlier speculation by a Wall Street analyst, Pfizer and Bristol-Myers…

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