FDA Approves Edoxaban to Reduce Stroke in AFib, VTE

The U.S. FDA has approved edoxaban (Savaysa, Daiichi Sankyo) to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation as well as for the treatment of venous thromboembolism.

The once-daily Xa-inhibitor tablet produced by Daiichi Sankyo Company, Limited was found to be non-inferior to warfarin in the ENGAGE AF-TIMI 48 trial in the reduction of stroke risk. The rate of cardiovascular death in Savaysa was also found to be less than warfarin (2.95% per year vs. 3.59% per year). Savaysa is also approved for deep vein thrombosis and pulmonary embolism following 5-10 days of initial therapy with a parenteral anticoagulant.

In the Hokusai-VTE trial, Savaysa 60 mg was non-inferior to warfarin for the recurrence of symptomatic venous thromboembolism (VTE) (3.2% vs. 3.5%, respectively; HR, 0.89; 95% CI, 0.70 to 1.13) and also had 19% less risk of relevant bleeding in patients with VTE compared to warfarin (8.5% vs. 10.3%, respectively; HR, 0.81; 95% CI, 0.71 to 0.94, p=0.004).

Savaysa does come with boxed warnings for patients with non-valvular atrial fibrillation with CrCL > 95 ml/min due to an increased rate of ischemic stroke compared to warfarin. Additionally, the FDA warns that premature discontinuation of Savaysa can increase the risk of ischemic events, and patients receiving neuraxial anesthesia or undergoing spinal puncture are at increased risk of epidural or spinal hematomas while on Savaysa.

In the trials, the most common adverse effects were bleeding, anemia, rash, and abnormal liver function tests. Savaysa should not be used with other anticoagulants, antiplatelets, and thrombolytics due to increased bleeding risk and should not be coadministered with rifampin.

Read the full press release here.