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AZ’s Farxiga heart failure results wow the ESC

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Chases after market leader Jardiance

AZ

AstraZeneca has already revealed that the DAPA-HF trial of AstraZeneca’s diabetes therapy Farxiga in heart failure with reduced ejection fraction (HFrEF) was a win, but now we know by how much.

Lead investigator John McMurray of the University of Glasgow presented the results at the European Society of Cardiology (ESC) congress in Paris over the weekend to an enthusiastic audience.

He said that Farxiga (dapagliflozin) reduced the composite of cardiovascular (CV) death or worsening of heart failure by 26% (p<0.0001) – with the benefit seen in both diabetic and non-diabetic patients – when added to standard therapy.

The headline result was unveiled last month, but until now cardiologists were unable to gauge the scale of the improvement with the SGLT2 inhibitor, which seemed to have a positive impact across all 14 prespecified subgroups in the trial. Farxiga also reduced the risk for all-cause death by 17%.

Farxiga is the first drug in the class to complete a cardiovascular outcomes trial in HFrEF, and could open up an entirely new treatment category for these patients – and a whole new revenue stream for AZ as it chases after SGLT2 market leader Jardiance (empagliflozin) from Eli Lilly and Boehringer Ingelheim.

McMurray said that Farxiga “did all the things we would like any drug to do in heart failure, which are to improve symptoms, reduce hospital admissions and increase survival”.

Meanwhile, the discussant for DAPA-HF at the ESC – Marco Metra of the University of Brescia in Italy – described it as a “landmark trial” that could usher in “a new era in heart failure medical treatment”.

Farxiga is already growing quickly for AZ on the back of data showing it can reduce cardiovascular and kidney complicationsin diabetics, but DAPA-HF could extend its use into the non-diabetic population and make it an option for the millions of patients worldwide with heart failure.

However, HFrEF only accounts for around half of all cases and cardiologists are hoping that Farxiga might also show activity in heart failure with preserved ejection fraction (HFpEF), a hard-to-treat form of the disease that currently has no approved drug therapies.

Farxiga is currently being studied in HFpEF in the DELIVER trial as well as the DETERMINE study, which is enrolling both HFrEF and HFpEF patients. Those trials are due to read out next year.

Boehringer and Lilly aren’t resting on their laurels however, and recently won a fast-track review from the FDA for Jardiance in both HFrEF and heart failure with preserved ejection fraction (HFpEF) based on two trials - EMPEROR-Reduced and EMPEROR-Preserved – that are also due to read out next year.

AZ is comfortably in the lead at the moment however, and can expect Farxiga sales to go up a gear if – as seems likely – the data is cleared by regulators. Farxiga brought in $1.4bn in sales for the company last year, just over half the $2.7bn made by Jardiance, and grew another 14% to $726m in the first half of 2019.

机器翻译

阿斯利康已经透露,阿斯利康的糖尿病疗法 Farxiga 在射血分数降低性心力衰竭 (HFrEF) 中的 DAPA-HF 试验是一个胜利,但现在我们知道有多少。格拉斯哥大学的首席研究员 John McMurray 在周末于巴黎举行的欧洲心脏病学会 (ESC) 大会上向热情的听众展示了这一成果。他说,将 Farxiga (dapagliflozin) 加入标准治疗后,心血管 (CV) 死亡或心力衰竭恶化的复合终点降低了 26% (p <0.0001),糖尿病和非糖尿病患者均可从中获益。上个月公布了标题结果,但直到现在心脏病学家仍无法衡量 SGLT2 抑制剂的改善程度,这似乎对试验中所有 14 个预先设定的亚组都有积极影响。Farxiga 还将全因死亡的风险降低了 17%。Farxiga 是该类药物中首个在 HFrEF 中完成心血管结局试验的药物,并可能为这些患者开辟一个全新的治疗类别——也是 AZ 的一个全新收入来源,因为它追赶的是礼来和勃林格殷格翰的 SGLT2 市场领导者 Jardiance(恩格列净)。McMurray 说,Farxiga“做了我们希望任何药物治疗心衰的所有事情,即改善症状、减少住院和提高生存率”。同时,意大利布雷西亚大学 ESC–Marco Metra 的 DAPA-HF 讨论者将其描述为“里程碑式的试验”,可能开创“心力衰竭医疗的新纪元”。Farxiga 在数据显示它可以减少糖尿病患者的心血管和肾脏并发症的基础上,已经在快速成长,但是 DAPA-HF 可以扩展它在非糖尿病人群中的应用,并使它成为全世界数百万心力衰竭患者的选择。然而,HFrEF 仅占所有病例的一半左右,心脏病专家希望 Farxiga 在射血分数保留性心力衰竭 (HFpEF) 患者中也能显示出活性,HFpEF 是一种难以治疗的疾病,目前尚无获批的药物治疗。目前正在 DELIVER 试验以及 DETERMINE 研究中研究 Farxiga 在 HFpEF 中的作用,该研究正在招募 HFrEF 和 HFpEF 患者。这些审判将于明年宣读。然而,Boehringer 和 Lilly 并没有停留在他们的荣誉上,并且最近赢得了 FDA 对 Jardiance 治疗 HFrEF 和射血分数保留性心力衰竭 (HFpEF) 的快速通道审查,这两项试验——EMPEROR-Reduced 和 EMPEROR-preserved——也将于明年宣读。不过,AZ 目前处于有利的领先地位,如果监管机构清除了数据,预计 Farxiga 的销量将大幅上升——这似乎是有可能的。Farxiga 去年为公司带来了 14 亿美元的销售额,略高于 Jardiance 27 亿美元的销售额,2019 年上半年又增长了 14%,达到 7.26 亿美元

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