Competing to treat patients with severe eosinophilic asthma (SEA), AstraZeneca has fared well matching its IL-5 inhibitor Fasenra up against GSK’s Nucala.But AZ has stumbled in its efforts to add indications to Fasenra's label. In 2022, the FDA rejected the medicine to treat rhinosinusitis. Then, later in the year, shaky trial data derailed the company’s bid for an approval in eosinophilic esophagitis (EoE).On Monday, however, the company revealed positive news for Fasenra as it has achieved its primary endpoint in the phase 3 MANDARA trial, demonstrating noninferior rates of remission in a head-to-head battle against Nucala in patients with eosinophilic granulomatosis with polyangiitis (EGPA).AZ did not provide numbers with the trial results.

为了治疗严重嗜酸性粒细胞性哮喘（SEA）患者，阿斯利康已经将其IL-5抑制剂Fasenra与GSK的Nucala进行了很好的匹配。但是AZ在努力为Fasenra的标签添加适应症方面绊倒了。2022年，FDA拒绝了治疗鼻-鼻窦炎的药物。然后，今年晚些时候，不稳定的试验数据使该公司批准嗜酸性粒细胞性食管炎（EoE）的出价脱轨。然而，在周一，该公司透露了Fasenra的积极消息，因为它已经在MANDARA 3期试验中达到了主要终点，在嗜酸性粒细胞肉芽肿伴多血管炎（EGPA）患者的头对头战斗中表现出非劣效的缓解率.AZ没有提供试验结果的数字。

Those will come at a future medical conference, the company said.With a 2017 label expansion, Nucala is the only treatment approved for EGPA. In proving noninferiority to Nucala, AZ's Fasenra did so with a smaller dosing regimen—one 30-mg subcutaneous injection every four weeks versus three 100-mg injections of Nucala over the same period.While the dosing edge is one positive for AZ's drug, remission is the primary focus for the company.“Our goal is to make remission a treatment goal for every patient with severe asthma and with EGPA,” Andrew Menzies-Gow, AZ’s global medical head of respiratory biologics, said in an interview.

公司说，这些将在未来的医疗会议上举行。随着2017年标签的扩大，Nucala是唯一批准用于EGPA的治疗方法。在证明Nucala的非劣效性时，AZ的Fasenra采用较小的给药方案-每四周皮下注射一次30 mg，而同期注射三次100 mg Nucala。虽然剂量优势是AZ药物的一个积极因素，但缓解是该公司的主要关注点。AZ全球呼吸生物制剂医学负责人Andrew Menzies Gow在接受采访时说：“我们的目标是使缓解成为每位患有严重哮喘和EGPA的患者的治疗目标。

“We feel that’s a goal that will dramatically shift how patients are treated today.”Asthma patients typically take on additional treatments as the severity of their disease increases, Menzies-Gow said. But with Fasenra’s ability to control disease, patients can be weaned off the added therapies. This week at the European Respiratory Society (ERS) International Congress in Milan, AZ is presenting evidence fro.

Menzies Gow说：“我们认为这一目标将大大改变今天患者的治疗方式。”随着疾病严重程度的增加，哮喘患者通常会接受额外的治疗。但随着Fasenra控制疾病的能力，患者可以从添加的治疗中断奶。本周在亚利桑那州米兰举行的欧洲呼吸学会（ERS）国际大会上提出了证据。

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One look: AstraZeneca unifies patient-physician messaging for asthma blockbuster Fasenra

一看：阿斯利康统一了哮喘重磅炸弹Fasenra的医患信息

In coming up short in a trial of EoE patients last year, Fasenra cleared the remission bar, topping placebo. But it failed to meet its other objective, which was to relieve swallowing issues (dysphagia) that come with the disorder.As for EGPA, which was formerly known as Churg-Strauss syndrome, the condition is a rare immune-mediated vasculitis that can damage the lungs, heart, skin, nerves and gastrointestinal system.

去年在EoE患者的试验中，Fasenra清除了缓解条，增加了安慰剂。但它未能达到另一个目标，即缓解伴随疾病的吞咽问题（吞咽困难）。至于以前称为Churg-Strauss综合征的EGPA，这种疾病是一种罕见的免疫介导的血管炎，可以损害肺，心脏，皮肤，神经和胃肠系统。

It is potentially fatal and affects roughly 118,000 people worldwide..

它可能致命，影响全球约118000人。。

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AstraZeneca goes to battle with GSK with nod for Nucala challenger Fasenra

阿斯利康与葛兰素史克和点头为Nucala挑战者Fasenra战斗

Fasenra binds to the IL-5 receptor alpha, directly targeting the eosinophils. Published evidence suggests there is a 'very rapid and near depletion of both blood and tissue eosinophils as a result of this mechanism of action,' Menzies-Gow said. The drug won its original approval in SEA back in 2017.It didn’t take Fasenra long to achieve blockbuster status, as the drug generated sales of $1.26 billion in 2021.

Fasenra与IL-5受体α结合，直接靶向嗜酸性粒细胞。Menzies Gow说，已发表的证据表明，由于这种作用机制，“血液和组织嗜酸性粒细胞非常迅速且几乎耗尽”。该药物于2017年在海上获得最初的批准。由于该药物在2021年的销售额为12.6亿美元，因此Fasenra很长时间才能实现重磅炸弹的地位。

But sustaining the growth rate has been difficult without gaining another indication. Last year, Fasenra sales increased (PDF) by 11% to $1.4 billion, compared to $1.86 billion for Nucala..

但是如果没有其他迹象，很难维持增长率。去年，Fasenra销售额增长（PDF）11%至14亿美元，而Nucala则为18.6亿美元。。