FDA Approves Dabigatran for Treatment of VTE and Reducing VTE Recurrence

April 07, 2014

RIDGEFIELD, CT – The US Food and Drug Administration (FDA) has approved dabigatran (Pradaxa, Boehringer Ingelheim) for treating deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days[1].

The FDA also approved dabigatran to reduce the risk of DVT/PE recurrence in patients who have been previously treated. The approval is based on four studies testing dabigatran in the setting of venous thromboembolism (VTE).

In the RE-COVER and RE-COVER 2 studies, patients with DVT and PE who had received initial parenteral anticoagulation, such as intravenous heparin or a subcutaneous low-molecular-weight heparin derivative, for five to 10 days were randomized to warfarin or dabigatran. These two trials showed the new anticoagulant was noninferior to warfarin in reducing DVT and PE and was associated with lower bleeding rates.

Two other studies— RE-MEDY , in which dabigatran was compared with warfarin in patients who had already received at least three months of anticoagulation for VTE, and RE-SONATE , in which dabigatran was compared with placebo in patients who previously received anticoagulant therapy for six to 18 months—formed the basis of the FDA approval and were previously reported by heartwire .

Dabigatran joins an increasingly crowded space of drugs already approved or seeking approval for indications related to DVT/PE. Rivaroxaban (Xarelto, Bayer/Janssen Pharmaceuticals) is approved in the US for the prevention of DVT, which may lead to lead to PE, in patients undergoing knee- or hip-replacement surgery. It is also approved for the treatment of DVT/PE and for the reduction in the risk of recurrent DVT/PE. Apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) was recently approved by the FDA for prophylaxis of VTE in adults who underwent hip- or knee-replacement surgery. It is not yet approved for use in preventing DVT and PE recurrence, but the company has submitted a supplemental new drug application to the FDA for this indication. Daiichi-Sankyo, the maker of edoxaban, which is not approved in the US, has applied to the European Medicines Agency seeking a VTE indication.

Dabigatran is a direct thrombin inhibitor currently approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The drug has come under fire of late, however, with Boehringer Ingelheim, the maker of dabigatran, facing more than 2000 lawsuits in the US over claims the drug caused severe and fatal bleeding.

In January, the FDA said it was requesting input from the public on a proposed study that will assess safety outcomes in adults with atrial fibrillation who recently started treatment with dabigatran or warfarin. The FDA hopes to assess the risk of ischemic stroke, intracranial hemorrhage, and major extracranial hemorrhage compared with warfarin-treated patients.


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