Search Results for: dabigatran

FDA Plans New Safety Assessment Of Dabigatran (Pradaxa)

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…

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Disappointing Results with Dabigatran for Mechanical Valves

Despite being more durable than bioprosthetic valves, mechanical heart valves are often not chosen because of the requirement for lifelong anticoagulant therapy. It has been hoped that the newer generation of oral anticoagulants might eventually replace warfarin, making anticoagulation more tolerable and better accepted, since these agents don’t require continuous monitoring and have much fewer…

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Registry Study Offers Reassurance About Safety And Efficacy Of Dabigatran

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…

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FDA Officials Calm Concerns Over Excessive Bleeding With Dabigatran

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…

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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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FDA Investigation Finds No Excess Bleeding Risk For Dabigatran

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…

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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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Growing Popularity Of Dabigatran Leads To Increased Complications

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…

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Study Explores Role of Periprocedural Dabigatran in AF Ablation

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…

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Excess Risk of Cardiac Events Associated with Dabigatran

Compared with controls, dabigatran (Pradaxa) is associated with a higher risk of myocardial infarction (MI) or acute coronary syndrome, according to a new meta-analysis published online in Archives of Internal Medicine. Ken Uchino and Adrian Hernandez analyzed data from seven clinical trials comparing dabigatran with warfarin, enoxaparin, or placebo in 30,514 patients. The rate of…

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FDA Undertakes Safety Review of Dabigatran (Pradaxa)

The FDA announced today that it was initiating a safety review of  dabigatran (Pradaxa, Boehringer Ingelheim). The review was prompted by reports of serious bleeding events in people taking the drug. Bleeding complications, the FDA acknowledges, are a “a well-recognized complication of all anticoagulant therapies.” The FDA said it was “working to determine whether the reports…

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Global Monitor: Early Signs of Possible Problems with ICD Leads, Dabigatran

Reports from Ireland and New Zealand may herald new concerns about the Riata defibrillator leads (St. Jude Medical) and dabigatran (Pradaxa). A poster presented at the European Society of Cardiology meeting last month by researchers at the Royal Victoria Hospital in Belfast found that  15% of 212 patients who received Riata leads had an insulation breach on…

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Pradaxa (Dabigatran) Off To A Strong Start

Boehringer-Ingelheim’s new oral anticoagulant dabigatran (Pradaxa) is off to a strong but not spectacular start. Wells Fargo analyst Larry Biegelsen reports that the drug has captured about 5% of the anticoagulant market since its launch last October. In the first quarter of 2011 the drug’s annualized sales were $285 million. The following charts (reprinted with…

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FDA Officials Offer Explanation For Absence of Low Dose Dabigatran

Following the approval last October of dabigatran some observers  criticized the FDA’s decision not to approve the lower 110 mg dose of the drug in addition to the higher 150 mg dose. Now, in a perspective in the New England Journal of Medicine, 3 FDA officials, B. Nhi Beasley, Ellis Unger, and Robert Temple, explain…

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FDA Warns Against Repackaging Dabigatran

The FDA has issued a safety communication regarding dabigatran (Pradaxa). Because the drug is subject to product breakdown and loss of potency due to moisture, the FDA recommends that it should be dispensed and stored in its original packaging and that consumers avoid using pill boxes or pill organizers with dabigatran….

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AF Guidelines Updated to Incorporate Dabigatran

Less than two months after the publication of the 2010 updated atrial fibrillation (AF) guidelines, the AHA, the ACC, and the HRS have released a new focused update incorporating recommendations and a discussion concerning the direct thrombin inhibitor dabigatran, which gains a Class I recommendation: Class I: Dabigatran is useful as an alternative to warfarin…

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RE-LY Substudy Finds Dabigatran Effective in Secondary Stroke Prevention

A substudy of the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial demonstrates that dabigatran is as effective in AF patients for secondary stroke prevention as it is for overall stroke prevention. In their paper in the Lancet Neurology, Hans-Christoph Diener and the RE-LY study group report the results of the trial in the predefined subset of…

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Is Dabigatran (Pradaxa) More Cost-Effective Than Warfarin in AF?

Dabigatran (Pradaxa), newly approved by the FDA to prevent stroke in patients with atrial fibrillation (AF), might turn out to be a cost-effective alternative to warfarin, according to an Annals of Internal Medicine study. Using data from the RE-LY trial, James Freeman and colleagues modeled the quality-adjusted survival and cost-effectiveness of dabigatran compared with high- or low-dose warfarin…

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Pradaxa (dabigatran) Goes On Sale Wednesday, November 3

Dabigatran (Pradaxa, Boehringer Ingelheim) will go on sale in drugstores on Wednesday, November 3, according to a press release issued by Boehringer Ingelheim. The press release confirms the previously reported wholesale acquisition price of $6.75 a day for two capsules. Knowledgeable experts estimate that therefore the retail price of Pradaxa will likely be $7.90 per day, or…

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Pradaxa (dabigatran) Pricing Starts to Emerge

It looks like Pradaxa (dabigatran) will cost about $237 a month at the drugstore counter. A Boehringer Ingelheim representative told CardioBrief that the wholesale acquisition cost (WAC) of the drug will be $6.75 per day for 2 pills. The price will apply to both the 150 mg and the 75 mg capsules.  According to knowledgeable experts,…

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Some Remaining Questions About Dabigatran

Yesterday’s approval of dabigatran (Pradaxa) has been long awaited in the cardiology community. Although just about everyone agrees that a good alternative to warfarin is highly desirable, there are many remaining questions about the drug as it prepares to enter the marketplace. Here are a few questions raised by electrophysiologist John Mandrola on his blog:…

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Dabigatran Gains FDA Approval

The FDA has approved dabigatran (Pradaxa) for the prevention of stroke and blood clots in patients with atrial fibrillation. Boehringer Ingelheim first announced the approval in a tweet (of all places). The FDA says the drug will be available in 75 mg and 150 mg capsules. (In its review of the drug the FDA had been critical of data…

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FDA panel unanimously recommends approval for dabigatran

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approval of dabigatran (Pradaxa, Boehringer-Ingelheim) for the prevention of stroke in patients with AF. The panel was split on whether both doses (150 mg bid and 110 mg bid) used in the RE-LY trial should gain approval, though in an informal straw…

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Soap opera star helps BI prepare the market for Pradaxa (dabigatran)

What can a soap opera star teach us about atrial fibrillation? Not much. But perhaps she can teach us a whole lot about pharmaceutical marketing in the 21st century. Her first lesson is about market preparation, or creating awareness and demand for a product before it’s available. In this case the product is Pradaxa, and BI…

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Approval likely for dabigatran as FDA posts positive briefing documents for advisory panel

A positive recommendation for dabigatran appears likely based on the extremely benign briefing documents posted by the FDA in preparation for Monday’s meeting of the Cardiovascular and Renal Drugs Advisory Committee. The panel will discuss the NDA for dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The conclusions and recommendations of…

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