Anticoagulant Savaysa Now Available for Prescribing

Daiichi Sankyo announced that Savaysa (edoxaban) tablets are now available to reduce the risk of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF), and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5–10 days of initial therapy with a parenteral anticoagulant.

Savaysa is an oral, once-daily selective inhibitor of factor Xa (FXa). It does not require antithrombin III for antithrombotic activity. It inhibits free FXa, prothrombinase activity, and thrombin-induced platelet aggregation. The FXa inhibition in the coagulation cascade reduces thrombin generation and reduces thrombus formation.

The FDA approval was based on data from the ENGAGE AF-TIMI 48 and Hokusai-VTE studies. In ENGAGE AF-TIMI 48, treatment with Savaysa had significantly less bleeding in patients with NVAF in the overall study population (HR 0.80; 95% CI: 0.70–0.91; P<0.001) and in those with CrCl ≤95mL/min (HR 0.84; 95% CI: 0.73–0.97). Also, there were lower rates of intracranial hemorrhage seen with Savaysa vs. warfarin in patients with NVAF (0.5% vs. 1.0% per year; HR 0.44; 95% CI: 0.32–0.61). In the Hokusai-VTE study population, Savaysa 60mg once daily proved non-inferior to warfarin for the primary efficacy endpoint of recurrence of symptomatic venous thromboembolism (VTE) (3.2% vs. 3.5%; HR 0.81; 95% CI: 0.71–0.94; P=0.004).

According to the labeling, Savaysa should not be used in NVAF patients with creatinine clearance levels >95mL/min because in that population there is an increased risk of ischemic stroke compared to warfarin.

Want to read more?