CardioExchange Archive

January 9th, 2015

FDA Approves New Oral Anticoagulant from Daiichi Sankyo

Larry Husten, PHD

And then there were four. Late Thursday the FDA announced that it had approved edoxaban, the new oral anticoagulant manufactured by Daiichi Sankyo. The drug will be marketed under the brand name of Savaysa and joins three other new drugs in the large and important new oral anticoagulant marketplace: dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis). All four drugs were […]

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November 3rd, 2014

Economic Study Finds VTE Prophylaxis with Low-Molecular-Weight Heparin Cost Effective

Larry Husten, PHD

Critically ill patients in the hospital are at high risk for developing venous thromboembolism (VTE). The 2011 PROTECT trial compared the two most common drug strategies used to prevent VTE — unfractionated heparin (UFH) and dalteparin, a low-molecular-weight heparin (LMWH) —  and found no difference between the two groups in the primary endpoint of the trial, leg deep-vein thrombosis. But […]

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August 21st, 2014

FDA Grants Apixaban Expanded Indication for Venous Thromboembolism

Larry Husten, PHD

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. The supplemental new […]

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April 7th, 2014

Dabigatran Approved for Treatment of DVT and PE

Larry Husten, PHD

Boehringer Ingelheim announced on Monday that the FDA has approved dabigatran (Pradaxa) for the treatment of venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. All three of the new oral anticoagulants — dabigatran, rivaroxaban (Xarelto), […]

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March 14th, 2014

Apixaban Gains Indication for DVT Prophylaxis After Knee and Hip Replacement Surgery

Larry Husten, PHD

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) and pulmonary embolism in patients who have undergone hip or knee replacement surgery. The DVT prophylaxis indication joins the previously approved indication of stroke prevention in patients who have […]

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December 18th, 2013

New Trial Confirms Role for Dabigatran in Venous Thromboembolism

Larry Husten, PHD

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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September 1st, 2013

Positive Results for Edoxaban in VTE/PE

Larry Husten, PHD

Findings from the Hokusai-VTE trial of edoxaban

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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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March 26th, 2012

Rivaroxaban Found Safe and Effective for Pulmonary Embolism

Larry Husten, PHD

In recent years rivaroxaban has been found to be effective in the prevention of venous thromboembolism (VTE) after orthopedic surgery, for the prevention of stroke in AF patients, and as additional therapy to conventional antiplatelet therapy in ACS patients. Now, a study presented at the American College of Cardiology meeting in Chicago and published simultaneously in […]

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