Daiichi Sankyo announced that the Food and Drug Administration (FDA) has approved Savaysa (edoxaban) tablets 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 a 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.
RELATED: Daiichi Sankyo Submits Savaysa NDA for Thromboembolic Disorders
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).
Savaysa will be available in 15mg strength tablets in 30-count bottles, and 30mg and 60mg strength tablets in 30-, 90- and 500-count bottles. Savaysa is expected to launch in February 2015.
For more information call (877) 437-7763 or visit DaiichiSankyo.com.