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news.The US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted in favour of the use of Japanese pharmaceutical firm Daiichi Sankyo’s Savaysa (edoxaban).
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The FDA committee voted nine to one to recommend approval of once-daily Savaysa 60mg dosing regimen for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF).
Daiichi Sankyo Company senior executive officer and global head of R&D and Daiichi Sankyo executive chairman and president Glenn Gormley said: "We are confident that the outcomes and robustness of the ENGAGE AF-TIMI 48 study fully support the approval in the US of the 60mg dosing regimen of Savaysa for patients with NVAF, with a dose reduction to 30 mg in selected patients.
"We will continue to work with the FDA as it completes its review of our New Drug Application for SAVAYSA for the prevention of stroke and SEE in patients with atrial fibrillation."
The recommendations were provided based on data from the ENGAGE AF-TIMI 48 trial, which showed that once-daily edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin for the reduction in risk of stroke and SEE in patients with NVAF.
Results also showed significantly less major bleeding compared to warfarin, achieving superiority for the principal safety endpoint of major bleeding.
Currently, the company is seeking approval from the FDA for the 60mg dosing regimen of edoxaban for the reduction in risk of stroke and SEE in patients with NVAF.
The company is also seeking approval of edoxaban to treat and prevent recurrence of symptomatic venous thromboembolism (VTE) based on the results from the Hokusai-VTE trial, which is the single largest comparative trial of a new oral anticoagulant in this patient population.