Japanese drug-maker Daiichi Sankyo has obtained approval from US Food and Drug Administration (FDA) for its anti-clotting drug Savaysa (edoxaban tablets).
Savaysa is an oral and once-daily selective factor Xa-inhibitor developed to reduce the risk of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF).
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Daiichi Sankyo president Joji Nakayama said: "The approval of Savaysa demonstrates our commitment to providing new treatment options for cardiovascular diseases with significant unmet needs and reinforces our leadership in factor Xa-inhibition research, which began more than 30 years ago.
"We look forward to making Savaysa available to patients in the US with NVAF and venous thromboembolism, two serious conditions that are expected to double in prevalence by mid-century."
Approval was based on data from the Engage AF-TIMI 48 and Hokusai-VTE studies, which included 30,000 patients.
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Engage AF-TIMI 48 was a three-arm, randomised, double-blind, double-dummy and global Phase III clinical study, which compared once-daily edoxaban with warfarin in 21,105 patients with NVAF at moderate-to-high risk of thromboembolic events at 1,393 centres in 46 countries.
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By GlobalDataHokusai-VTE was a randomised, double-blind, parallel-group Phase III clinical trial, which involved 8,292 patients in 439 clinical sites across 37 countries to assess once-daily edoxaban in patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE) or both.
The anti-clotting drug is not indicated for NVAF patients with creatinine clearance (CrCL) levels greater than 95ml / min due to an increased risk of ischemic stroke compared to warfarin, in the US population.
In 77% of patients with CrCL less than or equal to 95ml / min, Savaysa 60mg (30mg dose reduced) decreased the risk of stroke and SE compared to warfarin, and rates of cardiovascular death with Savaysa and warfarin were 2.95% each year against 3.59% every year, respectively.
Image: A 12-lead ECG showing atrial fibrillation at approximately 150 beats per minute. Photo: courtesy of James Heilman, MD.
