30 November 2020 07:00 GMT
Forxiga是日本批准的首个用于慢性心力衰竭伴射血分数降低的成人2型糖尿病患者的SGLT2抑制剂
AstraZeneca’s Forxiga (dapagliflozin)已在日本被批准用于接受标准治疗的慢性心力衰竭(HF)患者的治疗.
心衰是一种危及生命的慢性疾病，它会阻止心脏向全身输送足够水平的血液. It affects approximately 64 million people worldwide, at least half of whom have a reduced ejection fraction.1-3 当左心室肌肉不能充分收缩，因此向体内排出的富氧血液较少时，就会发生这种情况.4-6
The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on positive results from the landmark DAPA-HF Phase III trial published in The New England Journal of Medicine.7
Masafumi Kitakaze, Director of Hanwa Daini Senboku Hospital, Guest Professor of the Graduate School of Medicine, University of Osaka and Investigator of the DAPA-HF Phase III trial in Japan, said: “Heart failure is a condition affecting 1.3 million people in Japan. Many patients have considerably reduced heart function, such as left ventricular reduced ejection fraction. Approximately half of patients will die within five years of diagnosis, which is worse than some cancers. With no known cure except for heart transplant, 在目前的护理标准之上，一种新的有效治疗方案可能为与这种疾病作斗争的人带来希望，也为心脏病专家提供了一种新工具.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Forxiga在降低心血管死亡风险或心力衰竭事件恶化方面的疗效可能会为日本许多心力衰竭患者带来挽救生命的益处. 今天的批准将通过提供一种迫切需要的治疗方案来改善这些患者的结果和症状，从而改变澳门第一赌城在线娱乐管理这种疾病的方式.”
Forxiga 是否第一个钠-葡萄糖共转运蛋白2 (SGLT2)抑制剂在心血管(CV)死亡或心衰事件恶化的复合风险方面显示出统计学上显著的降低, including hospitalisation for HF (hHF). The DAPA-HF Phase III trial demonstrated that Forxiga, in addition to standard of care, 与安慰剂相比，复合结局的风险降低了26%，主要复合终点的两个组成部分都对总体效果有益.
In the DAPA-HF Phase III trial, the safety profile of Forxiga was consistent with the well-established safety profile of the medicine. During the trial, 每21例接受治疗的患者可避免1例CV死亡或hHF或因静脉治疗导致HF相关的紧急就诊.
Forxiga (known as Farxiga in the US) is approved in the US, Europe, 以及世界上其他几个国家用于治疗心力衰竭伴射血分数降低(HFrEF)患者.
Forxiga is advancing cardiorenal prevention as science continues to identify the underlying links between the heart, kidneys and pancreas. DAPA-HF is part of DapaCare, a robust clinical trial programme to assess the potential CV and renal benefits of Forxiga. 该项目还在开创性的DAPA-CKD III期试验中探索了慢性肾脏疾病(CKD)患者的治疗. Additionally, Forxiga 目前正在DELIVER III期试验中对保留射血分数(HFpEF)的HF患者进行测试，预计数据将于2021年下半年公布.
In 2013, AstraZeneca K.K. (AZKK), a subsidiary in Japan of AstraZeneca, entered into an agreement with Ono Pharmaceutical for Forxiga. Based on this agreement, Ono is responsible for distribution and marketing of Forxiga tablets in Japan and has been co-promoting it with AZKK for the treatment of T2D and type-1 diabetes. Both companies will co-promote for the treatment of chronic heart failure.
Heart failure
HF affects approximately 64 million people worldwide (at least half of whom have a reduced ejection fraction), including 1.3 million in Japan, 15 million in the EU and six million in the US.2-3,8,9 It is a chronic disease where half of patients will die within five years of diagnosis.10 HFrEF and HFpEF are the two main categories of HF related to ejection fraction, a measurement of the percentage of blood leaving the heart each time it contracts.7 HFrEF occurs when the left ventricle muscle is not able to contract adequately and therefore, expels less oxygen-rich blood into the body.5,6 在男性(前列腺癌和膀胱癌)和女性(乳腺癌)中，心衰仍然和一些最常见的癌症一样致命。.11 它是65岁以上老人住院的主要原因，是一个重大的临床和经济负担.12
DAPA-HF
DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) is an international, multi-centre, parallel-group, randomised, double-blinded trial in 4,744 patients with HFrEF (LVEF ≤ 40%), with and without T2D, designed to evaluate the effect of Forxiga 10mg, compared with placebo, given once daily in addition to standard of care. 主要综合终点为首次发生恶化心衰事件(住院或同等事件)的时间, i.e. an urgent heart failure visit), or CV death. The median duration of follow-up was 18.2 months.
Forxiga
Forxiga (dapagliflozin) is a first-in-class, oral, 每日一次的SGLT2抑制剂适用于成人治疗控制不足的T2D，可作为单一治疗和联合治疗的一部分，作为饮食和运动的辅助治疗，以改善血糖控制, with the additional benefits of weight loss and blood-pressure reduction.
Forxiga has been evaluated in patients with CKD in the Phase III DAPA-CKD trial, with the full results announced in August 2020 demonstrating that Forxiga met all primary and secondary endpoints, providing overwhelming efficacy. Forxiga is currently being tested for patients with HF in the DELIVER (HF with preserved ejection fraction, HFpEF) and DETERMINE (HFrEF and HFpEF) Phase III trials. Forxiga 在DAPA-MI试验中，也将在急性心肌梗死(MI)或心脏病发作后无T2D的患者中进行测试，这是同类试验的首例, indication-seeking registry-based randomised controlled trial. Forxiga 拥有强大的临床试验计划，包括超过35项已完成和正在进行的IIb/III期试验,000 patients, as well as more than 2.5 million patient-years’ experience.
AstraZeneca in CVRM
Cardiovascular, 肾脏和代谢(CVRM)共同构成澳门在线赌城娱乐的三大治疗领域之一，是公司的关键增长动力. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, 澳门在线赌城娱乐正在投资一系列药物，以保护器官，并通过减缓疾病进展来改善结果, reducing risks and tackling comorbidities. 该公司的目标是改变或停止crvrm疾病的自然过程，并可能使器官再生和恢复功能, 通过继续提供变革性的科学，改善全球数百万患者的治疗实践和心血管健康.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, 澳门在线赌城娱乐在100多个国家开展业务，其创新药物被全球数百万患者使用. Please visit charleighoffice.net and follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.
References
1. Mayo Clinic. Heart failure; 29 May 2020 [cited 21 October 2020]. Available from: URL: http://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.
2. Vos T et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. The Lancet 2017; 390(10100):1211–59.
3. Travessa AMR, Menezes Falcão LF de. Treatment of Heart Failure With Reduced Ejection Fraction-Recent Developments. Am J Ther 2016; 23(2):e531-49.
4. American Heart Association. Ejection Fraction Heart Failure Measurement; 2017 [cited 2 Nov 2020]. Available from: URL: http://www.heart.org/en/health-topics/heart-failure/diagnosing-heart-failure/ejection-fraction-heart-failure-measurement.
5. Ponikowski P et al. 2016 ESC急性和慢性心力衰竭诊断和治疗指南:欧洲心脏病学会(ESC)急性和慢性心力衰竭诊断和治疗工作组在ESC心力衰竭协会(HFA)的特殊贡献下制定. Eur Heart J 2016; 37(27):2129–200.
6. National Guideline Centre (UK). Chronic Heart Failure in Adults: Diagnosis and Management. London: National Institute for Health and Care Excellence (UK); 2018 Sep. (NICE Guideline, No. 106.) 13, Glossary.
7. McMurray JJV et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med 2019.
8. AstraZeneca. Data on File. November 2020.
9. Dickstein K, et al. ESC急性和慢性心力衰竭诊断和治疗指南2008:欧洲心脏病学会急性和慢性心力衰竭诊断和治疗工作组2008. 与ESC心力衰竭协会(HFA)合作开发，并得到欧洲重症监护医学协会(ESICM)的认可。. Eur Heart J 2008; 29:2388-2442.
10. Mozaffarian D et al. Circulation. 26 January 2016;133(4):e38-360 and the CDC: http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm.
11. Mamas MA et al. Do patients have worse outcomes in heart failure than in cancer? A primary care-based cohort study with 10-year follow-up in Scotland. Eur J Heart Fail 2017; 19(9):1095–104.
12. Azad N, Lemay G. Management of chronic heart failure in the older population. J Geriatr Cardiol 2014; 11(4):329–37.
Adrian Kemp
Company Secretary
AstraZeneca PLC