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Daiichi Sankyo Nordics ApSc/o

Edoxaban

In our portfolio since: 2015

Trademark: LIXIANA1

Indication:

Edoxaban is a once-daily, non-vitamin K antagonist (non-VKA) oral anticoagulant (NOAC) that specifically, reversibly and directly inhibits factor Xa, an important factor in the coagulation system that leads to blood clotting. It is used for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Clinical Trials:

The global edoxaban clinical trial program included the largest and longest antithrombotic trials to date.

  • ENGAGE AF-TIMI 48: With 21,105 patients the largest and longest (median follow-up duration of 2.8 years) trial to date for stroke prevention in atrial fibrillation.2,3
  • Hokusai-VTE: Included 8,292 patients and thus is the largest study to date of a non-vitamin K antagonist oral anticoagulant (NOAC) in venous thromboembolism (VTE) that studied patients with DVT and/or PE.4,5
  • HOKUSAI VTE-Cancer: The Hokusai VTE-Cancer study is the first randomised control trial of its size to directly evaluate the net clinical outcome for cancer associated VTE. It showed that oral edoxaban is non-inferior to subcutaneous injectable dalteparin, for the composite outcome of recurrent venous thromboembolism (VTE) and major bleeding in cancer-associated VTE6.

References

1. For legal reasons detailed information about prescription medicine may only be given to healthcare professionals.

2. Giugliano RP, Ruff CT, Braunwald E, et al. ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369(22):2093-2104.

3. Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955-962. 

4. Büller HR, Décousus H, Grosso MA, et al. Hokusai-VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013;369(15):1406-1415.

5. Kang N, Sobieraj DM. Indirect treatment comparison of new oral anticoagulants for the treatment of acute venous thromboembolism. Thromb Res. 2014;133(6):1145-1151.

6. N Engl J Med. 2018 Feb 15;378(7):615-624