11月6日 07:00 GMT
New indication expands use of Brilinta beyond cardiovascular disease
to patients with mild-to-moderate stroke
澳门葡京网赌游戏公司 Brilinta (ticagrelor) has been approved in the US to reduce the risk of stroke, a leading cause of disability and death worldwide, 急性缺血性脑卒中(美国国立卫生研究院卒中量表评分≤5分)或高危短暂性脑缺血发作(TIA)患者.
美国食品和药物管理局(FDA)的批准是基于泰利斯公司 III期试验的积极结果，该试验显示阿司匹林+ Brilinta 在急性缺血性卒中或TIA患者中，与单独服用阿司匹林相比，90mg可显著降低卒中和死亡的综合发生率.1 The decision follows the Priority Review designation granted by the FDA in July 2020.
Dr. 粘土约翰斯顿, 泰利斯公司 III期试验的首席研究员，奥斯汀德克萨斯大学戴尔医学院院长, US, said: “One in four patients who have had a stroke will experience a second one, with the risk particularly high within the first 30 days. 的批准 Brilinta 与阿司匹林联合使用是降低卒中复发风险的重要进展，也是医生和患者期待已久的好消息.”
Mene Pangalos, Executive Vice President, 澳门葡京赌博游戏 R&D, 他说:“在美国, 每40秒就有人中风，这对一个人的生活的影响是毁灭性的. Brilinta 一种成熟的药物对冠状动脉疾病患者有效吗, 澳门葡京赌博游戏现在可以将其应用于急性缺血性中风或短暂性脑缺血发作的患者.”
The 泰利斯公司 trial demonstrated that Brilinta 90mg used twice daily and taken with daily aspirin 为 30 days, 卒中和死亡的主要综合终点降低了17%(绝对风险降低= 1).1%; hazard ratio 0.83; 95% confidence interval 0.71-0.96, p=0.015), compared to aspirin alone in patients with an acute ischemic stroke or TIA.1 This was a statistically significant and clinically meaningful reduction. The primary composite endpoint was driven by a reduction in stroke.
The risk 为 severe bleeding events was 0.5% in patients receiving aspirin plus Brilinta 和0.1% 为 aspirin alone. The results were in line with the known safety profile of Brilinta.1 Full data from the 泰利斯公司 Phase III trial can be found in The New England Journal of Medicine.
在中国和欧盟，扩大批准适应症的监管申请也在接受监管审查 Brilique.
Brilinta 已在110多个国家被批准用于预防成年急性冠脉综合征(ACS)患者的动脉粥样硬化血栓事件，并在70多个国家被批准用于高危和心脏病发作患者心血管事件的二级预防. In May 2020, the US FDA approved a 新的指示 为 Brilinta 包括降低高风险冠状动脉疾病患者首次心脏病发作或中风的风险.
中风
缺血性中风是由于大脑某一区域的血液供应被阻断而引起的. A transient ischaemic attack, is a temporary blockage of the blood supply to a region of the brain, resulting in symptoms only lasting 为 a short amount of time. 中风 is a leading cause of disability and death worldwide.2 在美国，每40秒就有一人中风，每4分钟就有一人死于中风.3 About one in four strokes are recurrent, 在最初事件发生后的30天内，风险尤其高，而在更接近最初事件的时间段内，风险甚至更高.4,5
泰利斯公司
泰利斯公司 is an 澳门葡京网赌游戏-sponsored, 随机, 安慰剂对照, 双盲, 国际, 多中心, event-driven Phase III trial involving more than 11,000 patients from 28 countries. It tested the hypothesis whether aspirin plus Brilinta 在预防非心源性急性缺血性卒中或高危TIA患者卒中和死亡方面是否优于单独使用阿司匹林. 患者在急性缺血性卒中或高风险TIA症状发作24小时内随机分组，治疗30天. Study treatments were Brilinta 180mg loading dose on day 1, followed by 90mg twice daily on days 2-30, or matching placebo. All patients received open-label aspirin 300-325mg on day 1, followed by 75-100mg once daily on days 2-30. 主要疗效终点为30天到达卒中和死亡复合终点的时间. 根据冠状动脉闭塞的链激酶和组织纤溶酶原激活剂的全球使用(GUSTO)定义，主要安全性指标是首次严重出血事件发生的时间, which includes fatal bleedings, intracranial haemorrhage; and bleeding causing hemodynamic compromise requiring intervention.
Brilinta
Brilinta (ticagrelor) is an oral, reversible, direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation. Brilinta, together with aspirin, 已被证明可显著降低主要心血管不良事件(心脏病发作, stroke or CV death), in patients with ACS or a history of heart attack. 在美国， Brilinta 是否也适用于降低冠心病高危患者首次心脏病发作或中风的风险.
澳门葡京网赌游戏 in CVRM
心血管, 肾脏和代谢(CVRM)共同构成澳门葡京网赌游戏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, 澳门葡京网赌游戏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 co-morbidities. 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.
澳门葡京网赌游戏
澳门葡京网赌游戏 (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily 为 the treatment of diseases in three therapy areas - 肿瘤学, 心血管, 肾 & Metabolism, and 呼吸 & 免疫学. Based in 剑桥, UK, 澳门葡京网赌游戏在100多个国家开展业务，其创新药物被全球数百万患者使用. 请访问 澳门葡京网赌游戏.com and follow the Company on 推特 @澳门葡京网赌游戏.
联系人
For details on how to contact the Investor Relations Team, please click 在这里. For 媒体联系人, click 在这里.
参考文献
1. Brilinta (ticagrelor) prescribing in为mation. 澳门葡京网赌游戏 Pharmaceuticals LP.
2. Johnston SC, Amarenco P, Denison H, 等. Ticagrelor and aspirin or aspirin alone in acute ischemic stroke or TIA. [英]医学 2020; 383:207-217.
3. Virani SS, Alonso A, Benjamin EJ 等. 心脏病和中风统计- 2020年更新:美国心脏协会的一份报告. 循环. 2020;141(9):e139–e596.
4. 纸巾GJ. Secondary stroke prevention. 柳叶刀神经 2014; 13(2):178–94.
5. Coull AJ, Lovett JK, and Rothwell PM. 短暂性脑缺血发作或轻微中风后早期中风风险的人群研究:对公众教育和服务组织的影响. BMJ. 2004;328:326.
艾德里安·坎普
公司秘书
澳门葡京网赌游戏