The dossier of Edoxaban is available for B2B partners!
Four-year follow-up data reinforces the consistent effectiveness and safety of treatment with edoxaban in patients with atrial fibrillation (AF)
We are pleased to inform you that the USDMF for Edoxaban API has been submitted to the USFDA. Based on our process expertise
Zydus's Generic Edoxaban Receives Approval in the U.S.
MUNICH--(BUSINESS WIRE)--Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today announced new edoxaban data being presented at The European Society of Cardiology Congress 2022. These include insights from routine clinical practice via the ETNA-AF Registry, adding to the growing body of evidence reaffirming the efficacy and safety profile of edoxaban seen in randomised clinical trials across a range of atrial fibrillation (AF) patient populations.1,2,3 The data, focusing on AF patient groups with complex needs who experience worse outcomes, may have implications for how clinicians manage these groups in the future.1,2,3
Sophia Antipolis, France – 28 Aug 2021: Edoxaban is noninferior to warfarin and its analogues for adverse clinical events in patients with atrial fibrillation after transcatheter aortic valve implantation (TAVI). That’s the finding of late breaking research presented in a Hot Line session today at ESC Congress 20211 and published in the New England Journal of Medicine.2 The incidence of major bleeding was higher with edoxaban compared with vitamin K antagonists (VKAs).
MADRID - ( BUSINESS WIRE ) - Daiichi Sankyo Europe, (hereinafter Daiichi Sankyo) announced today multiple new data on edoxaban that will be presented at the ESC 2021 Congress, organized by the European Society of Cardiology. Among them are the results of routine clinical practice through the ETNA-AF Registry, which reaffirm the efficacy and safety profile of edoxaban demonstrated in randomized clinical trials in a series of patient populations with atrial fibrillation (AF). Furthermore, the results of the ENVISAGE-TAVI AF study, presented in a Hot Line session during the congress, compared the efficacy and safety of edoxaban with vitamin K antagonists (VKAs) in patients with AF who underwent implantation. successful transcatheter aortic valve. (TAVI).1 Trial results were published concurrently in The New England Journal of Medicine (NEJM) .
MUNICH--(BUSINESS WIRE)--Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today announced the presentation of new routine clinical practice outcomes data confirming, in line with the randomised clinical trial data, the consistent effectiveness and safety profile of LIXIANA® (edoxaban) in protecting against the risk of stroke in people with atrial fibrillation (AF). Over 13,000 patients were followed for two years in the ETNA-AF-Europe study, showing stroke and bleeding rates in line with rates seen after one year of follow-up. The data were presented at the annual scientific meeting of the European Heart Rhythm Association (EHRA 2021).1
Daiichi Sankyo Company Limited announced that it submitted an supplemental application in Japan for an expanded approved usage or dosage for the anticoagulant, edoxaban (edoxabantosilate hydrate), for elderly patients with non-valvular atrial fibrillation and high bleeding risk.
MUNICH, Aug. 31, 2020 /PRNewswire/ -- Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today announced one-year results of four sub-analyses from the European and global ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation) programme, a non-interventional safety study evaluating edoxaban treatment in routine clinical practice in >26,000 patients around the world with atrial fibrillation (AF).[1],[2],[3],[4] New 12-month data from the European and global ETNA-AF registries showed rates of bleeding and intracranial haemorrhage (ICH) were considered low by the authors' assessment in frail and ageing patients in routine clinical care.[1],[2],[3] Findings, which are part of the largest prospective, non-interventional study programme investigating a single direct oral anticoagulant (DOAC) in patients with non-valvular atrial fibrillation (NVAF) to date, are available virtually at ESC Congress 2020, the annual meeting of the European Society of Cardiology, taking place 29 August – 01 September.