New Analysis Identifies Patient Populations With Cancer-associated VTE Who Could Benefit From Treatment With Oral, Once-daily LIXIANA® (edoxaban)

Munich (ots/PRNewswire) – * Hokusai-VTE CANCER study showed that oral edoxaban is non-inferior
to subcutaneous injectable dalteparin, for the composite outcome of recurrent venous thromboembolism (VTE) and major bleeding in cancer-associated VTE

* This analysis provides benefit/risk assessment in different types of cancer patient populations[1]

* In those with non-gastrointestinal cancer, the risk of major bleeding was comparable[1]

* ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation), in AF patients at moderate-to-high risk of thromboembolic events

* Hokusai VTE (Edoxaban in Venous Thromboembolism), in patients with
either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE) or both

* ENSURE-AF (EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation), in AF patients undergoing electrical cardioversion

* ENTRUST-AF PCI (EdoxabaN TReatment versUS VKA in paTients with AF undergoing PCI), in AF patients undergoing percutaneous coronary intervention

* Hokusai-VTE Cancer (Edoxaban in Venous Thromboembolism Associated with Cancer), in patients with cancer and an acute VTE event

* ELDERCARE-AF (Edoxaban Low-Dose for EldeR CARE AF patients), in elderly AF patients in Japan

* ELIMINATE-AF (EvaLuatIon of edoxaban coMpared with VKA IN subjects
undergoing cAThEter ablation of non-valvular Atrial Fibrillation)

* ENVISAGE-TAVI AF (EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation (TAVI) – Atrial Fibrillation)

* ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation)

* ETNA-VTE (Edoxaban Treatment in routiNe clinical prActice in patients with Venous ThromboEmbolism)

* EMIT-AF/VTE (Edoxaban Management In diagnostic and Therapeutic procedures-AF/VTE)

* Prolongation PREFER in AF (PREvention oF thromboembolic events – European Registry) in patients with AF

* ANAFIE (All Nippon AF In Elderly) Registry in Japan

* Cancer-VTE Registry in Japan

1. Kraaijpoel N et al. Clinical Impact of Bleeding in Cancer-Associated Venous Thromboembolism: Results from the Hokusai
VTE Cancer Study. Thrombosis and Haemostasis. 2018 Aug;118(8):1439-1449. DOI: 10.1055/s-0038-1667001. Epub 2018 Jul 30.

2. Khorana AA, et al. Frequency, risk factors, and trends for venous
thromboembolism among hospitalized cancer patients. Cancer. 2007;110(10):2339-2346.

3. Hisada Y, et al. Venous Thrombosis and Cancer: from Mouse Models to Clinical Trials. Journal of Thrombosis and Haemostasis. 2015;13(8):1372-1382.

4. Imberti D et al. Antithrombotic therapy for venous thromboembolism in patients with cancer: expert guidance. Expert Opinion on Pharmacotherapy. 2018 Jul 16:1-9. DOI:
10.1080/14656566.2018.1496238. [Epub ahead of print]

5. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Cancer-Associated Venous
Thromboembolic Disease. Version 1.2018 – March 22, 2018.

6. Khorana AA, et al. Role of direct oral anticoagulants in the treatment of cancer-associated venous thromboembolism: guidance from the SSC of the ISTH. Journal of Thrombosis and Haemostasis, 16: 1-4. DOI:10.1111/jth.14219.

7. Van Es N, et al. Edoxaban for the treatment of venous thromboembolism in patients with cancer – rationale and design of the Hokusai-VTE-CANCER study. Thromb Haemost. 2015;114(6):1268-76.

8. Raskob GE, Van Es N, Verhamme P, Carrier M, Di Nisio M, Garcia DA, et al. LBA-6 A Randomized, Open-Label, Blinded Outcome Assessment Trial Evaluating the Efficacy and Safety of LMWH/Edoxaban Versus Dalteparin for Venous Thromboembolism Associated with Cancer: Hokusai-VTE-CANCER Study. Abstract presented at the Annual Society of Hematology Annual Meeting, 2017.

9. Raskob GE, van Es N, Verhamme, P, Carrier M, Di Nisio M, Garcia D, Grosso MA, Kakkar AJ, Kovacs MJ, Mercuri MF, Meyer G, Segers A,
Shi M, Wang TF, Zhang G, Zwicker JI, Weitz JI, Buller HR. Edoxaban
for the treatment of cancer-associated thromboembolism. N Engl J Med. 2018 Feb 15;378(7):615-624.

10. ClinicalTrials.gov. Cancer Venous Thromboembolism (VTE). Available at: https://clinicaltrials.gov/ct2/show/NCT02073682. [Last accessed: July 2018].

Lydia Worms (Europe)

Daiichi Sankyo Europe GmbH

Edoxaban Communications & Product PR Europe

+49-(89)-7808751

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