–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…
FDA Delays Approval Of First Agent To Reverse Effect Of New Anticoagulants
August 17, 2016 by Leave a Comment
Portola Pharmaceuticals announced late on Wednesday evening that it had received a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa). Approval for the drug had been widely expected earlier in the day, which was the drug’s PDUFA date. The drug had been on an accelerated…
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 Anticoagulant May Cut VTE In Medically Ill
May 27, 2016 by Leave a Comment
–Generally positive results for Portola’s betrixaban, despite missed key endpoint Betrixaban may yet become the first new oral anticoagulant to gain approval for extended venous thromboembolism (VTE) prophylaxis in the important and underserved group of medically-ill patients, even though its pivotal trial was damaged by a self-inflicted statistical wound. There were consistent differences in favor of…
Reality Check: After Starting Warfarin One In Five Older Vets Hospitalized For Bleeding
November 10, 2015 by Leave a Comment
A new study presented at the American Heart Association meeting in Orlando finds that more than one in five elderly US veterans are hospitalized for bleeding after starting warfarin. This high rate of serious bleeding complications in a real world setting surprised and even disturbed the study authors. Anticoagulants are the proverbial double-edged sword. Striking the right balance between benefit…
New Drug From Isis Breaks Important Ground But Unlikely To Dent The Market
December 7, 2014 by Leave a Comment
The first important results with a new drug under development by Isis Pharmaceuticals may well have an enormous long term impact on our understanding of how blood flows through the body and how that same blood forms clots in response to damage and disease. But it appears unlikely that the new drug– an anticoagulant unlike anything…
FDA Advisory Panel Gives Tepid Support To New Daiichi Sankyo Drug
October 31, 2014 by Leave a Comment
On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Daiichi Sankyo’s edoxaban(Savaysa), but the outcome will likely result in a drug that will be on the market but that few physicians will prescribe until further studies are performed. … Click here to read the full post on Forbes….
FDA Grants New Indication For Apixaban
August 21, 2014 by Leave a Comment
The FDA today approved an expanded indication for the oral anticoagulant apixaban (Eliquis, Bristol-Myers Squibb and Pfizer). Apixaban will now be indicated for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE (collectively known as venous thromboembolism) after initial therapy. … Click here to…
More Questions Raised About Boehringer Ingelheim’s Pradaxa
July 23, 2014 by 1 Comment
Once again dabigatran (Pradaxa) has raised the wrath of the critics. Several articles and an editorial published today in The BMJ raise more questions and concerns about the drug, which is the first of the new oral anticoagulants. Relying on new evidence along with previously disclosed data, Deborah Cohen, the investigations editor for The BMJ, casts doubt on the reliability…
FDA Places Clinical Hold On Phase 3 Trial Of Novel Anticoagulant
July 10, 2014 by Leave a Comment
A highly promising novel anticoagulant system now appears to be in serious difficulty. Regado Biosciences announced today that the FDA had placed a “clinical hold” on patient enrollment and dosing in the REGULATE-PCI trial, which is testing the Revolixys anticoagulation system. Revolixys consists of the Factor IX inhibitor pegnivacogin and an agent, anivamersen, which reverses its anticoagulant effect. REGULATE-PCI is a phase 3…
Boehringer Ingelheim Settles US Pradaxa Litigation For $650 Million
May 28, 2014 by 1 Comment
Boehringer Ingelheim said today that it will pay $650 million in a “comprehensive settlement” of lawsuits over Pradaxa (dabigatran), the company’s novel anticoagulant. The company said that it expects the settlement will resolve about 4,000 current cases against the company in the US. … Click here to read the full post on Forbes. …
FDA Study Provides Some Reassurance About Boehringer Ingelheim’s Pradaxa
May 13, 2014 by 1 Comment
In the latest development in its ongoing review of the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim), the FDA today offered largely reassuring news about the sometimes controversial drug. The FDA study of 134,000 Medicare patients found that dabigatran was associated with a reduced risk for ischemic stroke, bleeding in the brain, and death, compared to warfarin….
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 Plans New Safety Assessment Of Dabigatran (Pradaxa)
January 3, 2014 by Leave a Comment
Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the US in 2010 there have been persistent and lingering concerns about the drug’s safety. Now the FDA plans to perform a large new assessment of the drug compared to warfarin. n December 30 the FDA posted a request for public comment on a…
Large Study Finds Favorable Risk-Benefit Profile For The New Anticoagulants
December 5, 2013 by Leave a Comment
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…
FDA Spanks 23andMe, Grants Breakthrough Status To Factor Xa Inhibitor, and Approves Promus Premier Stent
November 25, 2013 by Leave a Comment
It was a busy morning at the FDA. Three new FDA actions may be of considerable interest in the cardiology universe: FDA Halts 23andMe Personal Genome Test– The FDA sent a scathing letter to 23andMe ordering the company to stop selling its Personal Genome Service (PGS) test. The FDA highlighted two cardiology-related uses of PGS as “particularly concerning,”…
Registry Study Offers Reassurance About Safety And Efficacy Of Dabigatran
April 4, 2013 by Leave a Comment
As the first new oral anticoagulant since warfarin, dabigatran (Pradaxa, Boehringer-Ingelheim) has been subject to intense concerns over its safety and efficacy in a real-world population. Last November an FDA investigation found no indication that bleeding rates for dabigatran were any higher than bleeding rates for warfarin. A new study from Scandinavia, published in the Journal of the American…
FDA Officials Calm Concerns Over Excessive Bleeding With Dabigatran
March 13, 2013 by 1 Comment
Concerns over excessive bleeding complications with dabigatran (Pradaxa, Boehringer Ingelheim) as compared with warfarin are most likely due to the heightened sensitivity and vigilance that can accompany a new drug, according to FDA officials in a perspective published online in the New England Journal of Medicine. “We believe that the large number of reported cases…
2012 In Review: A Bad Year For Conventional Wisdom
December 24, 2012 by 3 Comments
This was a really grim year for anyone who thought we had things pretty well figured out. Time and again conventional wisdom was thrown out the window. 2012 forced the cardiology community to reconsider what it thought it knew about HDL cholesterol, platelet function tests, aspirin resistance, triple therapy, IABP, and more. One device company,…
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…
FDA Investigation Finds No Excess Bleeding Risk For Dabigatran
November 2, 2012 by 1 Comment
In its latest assessment of a highly controversial issue, the FDA has found no indication that bleeding rates for dabigatran (Pradaxa, Boehringer-Ingelheim) are any higher than the bleeding rates for warfarin. The FDA investigation was in response to the large number of post-marketing reports of bleeding in people taking dabigatran. Click here to for the…
FDA Sets New Decision Date For Eliquis (Apixaban)
September 27, 2012 by Leave a Comment
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 BristolMyers Squibb. The new drug application (NDA) for stroke prevention in atrial fibrillation has been delayed twice. Although the pivotal ARISTOTLE trial was…
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…
Growing Popularity Of Dabigatran Leads To Increased Complications
June 7, 2012 by 1 Comment
Since its approval in the United States in October 2010 dabigatran (Pradaxa) has been prescribed 3.2 million times to more than 600,000 patients with nonvalvular atrial fibrillation (AF), according to its manufacturer, Boehringer Ingelheim. The company also announced that, based on the pivotal RE-LY trial, the “Clinical Studies” section of the drug’s prescribing information now…
Recent Comments