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AZ's Fasenra keeps the heat on Nucala with new data

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AstraZeneca’s Fasenra is already pressuring GlaxoSmithKline's Nucala in severe eosinophilic asthma, and new data could help set up a showdown between the two in another indication.

By week 12 of a phase 2 study in hypereosinophilic syndrome (HES), Fasenra cut patients' blood eosinophil counts by at least half, AstraZeneca showed with results published Thursday. Only 30% of patients taking placebo reached that mark. 

In patients with biopsies taken, results showed a “near-complete depletion” of eosinophils, the company said.

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“We are encouraged by these trial results for Fasenra in hypereosinophilic syndrome and the data are potentially important given the limited treatment options for this debilitating disease,” Mene Pangalos, AstraZeneca’s EVP of pharma R&D, said in a statement.

AstraZeneca spokeswoman Abigail Bozarth said the estimated U.S. population affected by HES, a rare disease that can lead to fatal organ damage, is around 20,500, but the number could be higher. 

"Given the challenges in diagnosing the disease, it’s likely that number is actually higher," Bozarth said in an email. "The global prevalence of HES is currently unknown, primarily due to the rare nature of this group of diseases and difficulty in diagnosis."

But Fasenra’s positive showing could spell trouble for GSK’s Nucala, which is currently in phase 3 trials for HES treatment.

Both drugs—alongside Sanofi’s Dupixent—are in a heated severe asthma race after Fasenra and Dupixent entered the field in November 2017 and October 2018, respectively.

GSK’s Nucala, which was approved to treat severe eosinophilic asthma in late 2015, initially shrugged off its competition in the field but later admitted to being unprepared for Fasenra’s challenge to the throne.

RELATED: GSK executives change their tune as AZ, Sanofi heap pressure on respiratory hopeful Nucala

“If you go back 12 months ago, I think we were very much behind on several parameters in terms of the perception of Nucala versus Fasenra,” Luke Miels, GSK’s pharma chief, said on the company's third-quarter conference call in November.

One area in which GSK has admitted Fasenra has the upper hand is in dosing. Nucala requires an injection every four weeks, while Fasenra requires treatment every eight weeks—an advantage Miels said couldn’t be “neutralized.”

Across the pond, Fasenra received a nod from the National Institute of Health and Care Excellence (NICE) in January that allowed the drug to reach an expanded pool of patients in England and Wales. Initially, the English drug watchdog only recommended Fasenra in patients for whom Nucala was not appropriate, but the new backing helped Fasenra compete in a wider market.

RELATED: AstraZeneca’s Fasenra puts more pressure on GSK’s Nucala with expanded NICE backing

In 2018, Fasenra secured $218 million in U.S. sales compared with £341 million ($446.27 million) for Nucala.

As the competition in severe asthma stiffens, GSK said it was placing its hopes on an at-home injector that could help swing the tide back in its favor. However, both companies will also compete with Sanofi’s Dupixent, the newest entry into the field.

RELATED: Sanofi's Dupixent set for $2.5B in peak asthma sales after scoring winning label: analyst

After its October FDA approval, analysts estimated Dupixent would boost Sanofi’s sales by $2.5 billion through what one analyst called, “the Goldilocks of labels compared to rivals.” 

Dupixent also stands to benefit as the only eosinophilic asthma treatment that can be administered at home—a point of pride that GSK will challenge with the 2019 scheduled release of its at-home injector.

机器翻译

阿斯利康的 Fasenra 已经在对葛兰素史克的 Nucala 在重度嗜酸粒细胞性哮喘施加压力,新的数据可能有助于在另一个适应症中设置两者的摊牌。阿斯利康公司周四公布的结果显示,在一项针对高嗜酸性粒细胞综合征 (HES) 的 2 期研究中,Fasenra 在第 12 周时将患者的血嗜酸性粒细胞计数至少减少了一半。只有 30% 的服用安慰剂的患者达到了这个标准。该公司说,对患者进行活检,结果显示嗜酸性粒细胞“几乎完全耗竭”。像这样的免费每日通讯?订阅 FiercePharma!生物制药是一个快速增长的世界,每天都有大的想法出现。我们的订户依赖 FiercePharma 作为他们的必读信息来源,获取关于药品及其生产商的最新消息、分析和数据。今天注册,以获得医药新闻和更新交付到您的收件箱和阅读走。阿斯利康制药研发部的执行副总裁 Mene Pangalos 在一份声明中说:“我们对 Fasenra 治疗高嗜酸性粒细胞综合征的试验结果感到鼓舞,考虑到这种使人虚弱的疾病的治疗选择有限,数据可能是重要的。”阿斯利康的发言人 Abigail Bozarth 说,HES 是一种罕见的可导致致命器官损伤的疾病,估计美国人口中约有 20,500 人,但这个数字可能会更高。Bozarth 在一封电子邮件中说,考虑到诊断这种疾病的挑战,这个数字实际上可能更高。‘HES 的全球患病率目前尚不清楚,主要是由于这组疾病的罕见性质和诊断的困难。但 Fasenra 的积极表现可能会给 GSK 的 Nucala 带来麻烦,目前 Nucala 正处于 HES 治疗的 3 期试验阶段。这两种药物——与赛诺菲的 Dupixent 一起——在 Fasenra 和 Dupixent 分别于 2017 年 11 月和 2018 年 10 月进入该领域后,正处于激烈的严重哮喘竞争中。GSK 的 Nucala 于 2015 年底获批治疗重度嗜酸粒细胞性哮喘,起初对其在该领域的竞争不屑一顾,但后来承认对 Fasenra 挑战王位毫无准备。相关:GSK 的高管们改变了他们作为 AZ 的调子,赛诺菲对呼吸有希望的 Nucala 堆压“如果你回到 12 个月前,我认为我们在 Nucala 与 Fasenra 的认知方面非常落后的几个参数,”GSK 的制药主管 Luke Miels 在 11 月公司的第三季度电话会议上说。GSK 承认 Fasenra 占据上风的一个领域是给药。Nucala 要求每 4 周注射一次,而 Fasenra 要求每 8 周治疗一次——Miels 说这是一个无法被“中和”的优势。“在池塘的另一边,Fasenra 在 1 月份获得了国家卫生与保健优化研究所 (NICE) 的点头,这使得该药能够到达英格兰和威尔士扩大的患者群。最初,英国药物监管机构只推荐 Fasenra 用于 Nucala 不适合的患者,但新的支持帮助 Fasenra 在更广泛的市场上竞争。相关:阿斯利康的 Fasenra 给 GSK 的 Nucala 带来了更大的压力,2018 年扩大了 NICE 的支持,Fasenra 获得了 2.18 亿美元的美国销售额,而 Nucala 为 3.41 亿英镑(4.4627 亿美元)。由于严重哮喘的竞争越来越激烈,GSK 表示,它正寄希望于一种家用注射器,这种注射器可能有助于使形势向有利于它的方向摆动。不过,两家公司也将与赛诺菲的 Dupixent 竞争,后者是该领域的最新进入者。相关:赛诺菲的 Dupixent 在赢得标签后设定了 25 亿美元的哮喘销售峰值:分析员在 10 月份获得 FDA 批准后,分析员估计 Dupixent 将通过一位分析员所称的“与竞争对手相比标签的黄金锁”将赛诺菲的销售额提升 25 亿美元。"Dupixent 作为唯一可以在家中给药的嗜酸粒细胞性哮喘治疗药物,也将从中获益——这一点是 GSK 将挑战的,GSK 计划在 2019 年发布其在家中的注射器

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