2020年10月28日07:00 GMT
Update to approval includes DECLARE-TIMI 58 Phase III trial that reduced the risk
of composite of hospitalisation for heart failure or cardiovascular death in type-2 diabetes
China’s National Medical Products Administration (NMPA) has updated the label for AstraZeneca’s Forxiga (dapagliflozin)纳入DECLARE-TIMI 58 III期试验的数据.
DECLARE-TIMI 58 证明了 Forxiga achieved a statistically significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or cardiovascular (CV) death, 与安慰剂, in adults with type-2 diabetes (T2D) and established CV disease or multiple CV risk factors. 试验证实了…的安全性 Forxiga.1
DECLARE-TIMI 58 is the largest sodium-glucose cotransporter 2 (SGLT2) inhibitor CV outcomes trial conducted to date, 试验数据发表在 新英格兰医学杂志 2019年1月.
There are an estimated 463 million people living with diabetes worldwide, 中国有近1.2亿人口.2 Patients with T2D are two to five times more likely to develop chronic heart failure (HF) than those without T2D.3
Ruud Dobber, 执行副总裁, 澳门葡京赌博游戏事业部, said: “Heart failure is one of the first cardiovascular complications for patients with type-2 diabetes. DECLARE-TIMI 58 III期数据显示 Forxiga 降低因心力衰竭住院的风险, 通过这个标签更新, we look forward to bringing this significant benefit to patients in China.”
Forxiga is indicated as a monotherapy and as part of combination therapies to improve glycaemic control in adults with T2D. NMPA标签更新, 基于DECLARE-TIMI 58 III期数据, 随着欧盟上市许可的更新 August 2019 并获得美国食品和药物管理局(FDA)的批准 2019年10月 有迹象表明 Forxiga (known as Farxiga in the US) to reduce the risk of hHF in adults with T2D and established CV disease or multiple CV risk factors.
In May 2020, Farxiga was approved in the US to reduce the risk of CV death and hHF in adults with HF (NYHA class II-IV) with reduced ejection fraction (HFrEF) 不论有无T2D, and in 2020年10月 Forxiga was recommended for approval for HF in the EU by the Committee for Medicinal Products for Human Use. 此外，FDA批准了 Farxiga 突破性疗法认定 2020年10月 to accelerate the development and regulatory review for patients with chronic kidney disease (CKD), 不论有无T2D.
2型糖尿病
T2D is a chronic disease characterised by pathophysiologic defects leading to elevated glucose levels, 或高血糖症.2 Over time, this sustained hyperglycaemia contributes to further progression of the disease.2 The prevalence of diabetes is projected to reach 578 million people worldwide by 2030, 到2045年将达到7亿.2 T2D accounts for approximately 90-95 percent of all cases of diagnosed diabetes.4
DECLARE-TIMI 58
DECLARE-TIMI 58是澳门葡京网赌游戏赞助的, Phase III, randomised, 双盲, 安慰剂对照, 多中心试验旨在评价 Forxiga compared with placebo on CV outcomes in adults with T2D at risk of CV events, including patients with multiple CV risk factors or established CV disease, 同时也评估了关键的肾脏次要终点. 审判包括超过17人,000名患者 across 882 sites in 33 countries and was independently run in collaboration with academic investigators from the TIMI study group (Boston, 美国)和哈达萨希伯来大学医学中心(耶路撒冷), Israel).1
Forxiga
Forxiga (达格列净)是一流的, oral, once-daily SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycaemic control, 还有额外的减肥和降血压的好处.
Forxiga 在III期DAPA-CKD试验中对CKD患者进行了评估, 随着全部结果的公布 August 2020 证明 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和decide (HFrEF和HFpEF) III期试验. Forxiga will also be tested in patients without T2D following an acute myocardial infarction (MI) or heart attack in the DAPA-MI trial - a first of its kind, 循证注册的随机对照试验. Forxiga has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000名患者, 以及超过2个.500万病人年的经验.
澳门葡京网赌游戏在crvrm
心血管，肾脏和代谢 (CVRM) together forms one of AstraZeneca’s three therapy areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, 肾脏和胰腺, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, 减少风险和处理合并症. The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.
AstraZeneca
澳门葡京网赌游戏(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门葡京赌博游戏公司，专注于发现, 处方药的开发和商业化, primarily for the treatment of diseases in three therapy areas - Oncology, 心血管, Renal & 新陈代谢和呼吸 & Immunology. 总部设在剑桥, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 ospifse.net 并在Twitter上关注公司 @AstraZeneca.
Contacts
References
1. Wiviott SD等. 达格列净和2型糖尿病的心血管结局. [英]医学 2019; 380(4):347–57.
2. 国际糖尿病联合会. IDF糖尿病图集第九版2019. 可从:网址: http://diabetesatlas.org/upload/resources/material/20200302_133351_IDFATLAS9e-final-web.pdf (2020年10月25日获取).
3. Ofstad AP等. The heart failure burden of type 2 diabetes mellitus-a review of pathophysiology and interventions. 心力衰竭 2018; 23(3):303–23.
4. 美国疾病控制与预防中心. 糖尿病快讯. 可从:网址: http://www.cdc.gov/diabetes/basics/quick-facts.html (2020年10月25日获取).
Adrian Kemp
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