Dabigatran Approved for Treatment of DVT and PE

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), and apixaban (Eliquis) — have now received FDA approval for the major indication of stroke prevention in patients with nonvalvular atrial fibrillation (SPAF). Rivaroxaban and dabigatran are also approved for the treatment of people who have or have had VTE, while rivaroxaban and apixaban are approved for DVT prophylaxis following hip or knee replacement surgery.

One significant difference between the drugs is that both apixaban and rivaroxaban were studied using a single-drug approach for acute use in the hospital and for continued use afterwards. By contrast, dabigatran was studied in patients after they had received parenteral anticoagulants and is indicated for use following treatment with a parenteral anticoagulant for 5 to 10 days. It can also be used in people who have been previously treated for VTE.

The new indication is based on results from four global Phase III studies evaluating the efficacy and safety of dabigatran in the treatment of DVT and PE: RE-COVER, RE-COVER II, RE-MEDY, and RE-SONATE.

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April 7th, 2014