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.
Savaysa is available in 15mg, 30mg and 60mg strength tablets.
For more information call (877) 437-7763 or visit DaiichiSankyo.com.