New Tx Approved for VTE, Stroke Risk Reduction

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.

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.

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