Health Canada approves edoxaban for two indications

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Health Canada has approved edoxaban (Lixiana, Servier Canada) for the prevention of stroke and for systemic embolic events in patients with non-valvular atrial fibrillation, in whom anticoagulation is appropriate and for treatment of venous thromboembolism (deep vein thrombosis, pulmonary embolism) and the prevention of recurrent deep vein thrombosis and pulmonary embolism.

According to a company release from Servier Canada, the approval of edoxaban is based on data from two phase 3 trials, ENGAGE AF-TIMI 48 and Hokusai- venous thromboembolism, which compared treatment with once-daily edoxaban to warfarin, a current standard of care for stroke prevention in patients with AF or for the treatment and prevention of venous thromboembolism. These studies represent the largest and longest clinical development of a novel oral anticoagulant in patients with non-valvular atrial fibrillation or venous thromboembolism, involving 21,105 and 8,292 patients, respectively.

” The data behind the two phase 3 trials that led to the approval of edoxaban in Canada are robust and edoxaban represents an important step forward in the treatment of these two conditions. I am confident that having edoxaban in our armamentarium of anticoagulants will help us better manage our patients with atrial fibrillation and venous thromboembolism “, says Jeffrey Weitz, professor of Medicine and Biochemistry at McMaster University, executive director of the Thrombosis and Atherosclerosis Research Institute and haematologist at Hamilton Health Sciences (all Hamilton, Canada).

“Health Canada’s approval provides another treatment option to physicians and patients in need of anticoagulation treatment. Edoxaban is the only once daily novel anticoagulant that has shown to protect from stroke and systemic embolic events as well as warfarin, while being associated with less major bleeding than well-managed warfarin, across a broad range of non-valvular atrial fibrillation patients” says Paul Dorian, professor of Medicine and Director, division of Cardiology at University of Toronto, Toronto, Canada and cardiac electrophysiologist at the St-Michael’s hospital.

In the ENGAGE AF-TIMI 48 study, once-daily edoxaban vs. warfarin demonstrated in a broad range of non-valvular atrial fibrillation patients:

  • Similar efficacy for the reduction of stroke and systemic embolic events (p value for noninferiority <0.001).
  • Superior safety with less major bleedings (relative risk reduction of 20%, p<0.001).
  • In the Hokusai- venous thromboembolism study, once daily edoxaban versus warfarin demonstrated across a broad range of venous thromboembolism patients:
  • Similar efficacy in the reduction of the symptomatic recurrence of venous thromboembolism, including deep vein thrombosis and fatal and non-fatal pulmonary embolism (p value for noninferiority <0.001).
  • Superior safety with less major or clinically relevant nonmajor bleeding (relative risk reduction 19%, p=0.004).