DAIICHI-SANKYO

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

“AF is a long-term condition which puts people at an increased risk of stroke, so it is very important that we have treatments that can provide benefits over the long term,” said Joris R. de Groot, MD, PhD, FESC, Professor of Cardiac Electrophysiology and Atrial Fibrillation at University of Amsterdam; Cardiologist at the Amsterdam University Medical Centers, Amsterdam the Netherlands. “We are seeing that more frail patients receiving the lower dose of edoxaban are not at increased risk of intracranial haemorrhage and are benefitting from treatment. This underlines the importance of prescribing anticoagulant therapy even for ageing AF patients.”

Event rates for stroke and death were 0.69% and 3.80% per year respectively. Some patients were prescribed the lower dose of edoxaban (30mg) for reasons including renal impairment. Annual event rates of intracranial haemorrhage were similar for both 60mg (0.2%) and 30mg (0.22%) doses. As a study investigating treatment in routine clinical practice, the data show that the majority of patients were using the recommended dose (83%).

The two-year outcome data in 13,417 patients across 10 European countries were from the European 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 for AF. ETNA-AF-Europe is part of the global ETNA-AF programme, which is the largest prospective, non-interventional study programme investigating a single non-vitamin K antagonist oral anticoagulant (NOAC) in patients with non-valvular atrial fibrillation (NVAF) to date.

Additional data in 27,617 people with AF from the global ETNA-AF programme were also presented at EHRA 2021, confirming that the stroke and bleeding rates under use of edoxaban at two years were also considered low and in line with randomised clinical trials in this larger, global data set. Patients with AF benefitted from edoxaban treatment across age groups, including the very elderly (≥85 years), in routine clinical care.^2,3

“These data underline the importance of providing effective treatment for elderly and frail AF patients, who are already at higher risk of strokes and, as confirmed by these real-world data, benefit from edoxaban treatment,” said Dr. Garth Virgin, Executive Director Medical Affairs Specialty Medicines at Daiichi Sankyo Europe. “The ETNA-AF programme is a huge undertaking that is providing critical insights into patient outcomes in routine clinical practice, and we are truly grateful for all the healthcare professionals and patients who are helping to make it possible.”

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About ETNA-AF: https://www.daiichi-sankyo.eu/media/about-etna-af

About AF: https://www.daiichi-sankyo.eu/media/about-etna-af

About Edoxaban: https://www.daiichi-sankyo.eu/media/about-etna-af

About the Edoxaban Clinical Research Programme, EDOSURE: https://www.daiichi-sankyo.eu/media/about-etna-af

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com .

Forward-looking statements: https://www.daiichi-sankyo.eu/media/about-etna-af

References

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¹ De Caterina R, et al. Safety and effectiveness of edoxaban in a real-world clinical setting: Two-year follow-up of the ETNA-AF-Europe study. Presentation at EHRA Congress 2021.

² Dinshaw L, et al . Annualized clinical event rates during two-year follow-up are low in 27,617 atrial fibrillation patients on edoxaban: Results from the global noninterventional ETNA-AF program. Presentation at EHRA Congress 2021.

³ Morrone D, et al . Low bleeding and stroke rates with minor age-dependent increase confirm the safety and effectiveness of edoxaban in patients with atrial fibrillation across all age groups: Two-year results from ETNA-AF. Presentation at EHRA Congress 2021.

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