January 3rd, 2014
FDA Plans New Safety Assessment of Dabigatran (Pradaxa)
Larry Husten, PHD
Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the U.S. 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. On December 30 the FDA posted a request for public comment on a proposed […]
November 26th, 2013
Edoxaban and the Changing Landscape of Novel Anticoagulants for Atrial Fibrillation
Christian Thomas Ruff, MD, MPH
Christian Thomas Ruff, a coauthor of the ENGAGE AF-TIMI 48 trial of edoxaban versus warfarin in patients with atrial fibrillation, discusses the future of novel anticoagulants.
June 28th, 2013
FDA Turns Back New Indication for Rivaroxaban to Prevent Stent Thrombosis in ACS Patients
Larry Husten, PHD
Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) 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 […]
March 22nd, 2013
Europe and U.S. Diverge on Two New Drugs
Larry Husten, PHD
The U.S. 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 […]
March 13th, 2013
FDA Officials Calm Concerns Over Excessive Bleeding with Dabigatran
Larry Husten, PHD
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 of bleeding associated […]
November 15th, 2012
In Acute VTE, Novel Oral Anticoagulants and Conventional Therapy Show Similar Efficacy
Nicholas Downing, MD
Novel oral anticoagulants and vitamin K antagonists offer similar protection against venous thromboembolism recurrence, according to a BMJ meta-analysis. However, one of the newer agents, rivaroxaban, seems to offer better protection against bleeding. The analysis included nine randomized controlled trials comparing apixaban, dabigatran, rivaroxaban, or ximelagatran (no longer on the market) with traditional vitamin K antagonists […]
November 3rd, 2012
Rivaroxaban Gains FDA Indications for Treating and Preventing DVT and PE
Larry Husten, PHD
The FDA has 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 for recurrent DVT and PE. The oral anticoagulant is already approved to reduce postsurgical risk for DVT and PE after hip- and knee-replacement surgery and to reduce […]
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