Regulators in the EU, China, and Japan have started reviews of GSK's depemokimab, aiming to become the first drug for severe asthma that can be given just twice a year.

欧盟、中国和日本的监管机构已经开始审查葛兰素史克的depemokimab，旨在成为第一种每年只能服用两次的治疗严重哮喘的药物。

The EMA and counterparts in China and Japan are assessing the anti-IL-5 antibody as an add-on maintenance treatment for asthma patients aged 12 and over who have eosinophilic asthma, a form associated with type 2 inflammation, and whose symptoms can't be controlled with medium to high doses of corticosteroids plus another asthma drug..

EMA和中国和日本的同行正在评估抗IL-5抗体作为12岁及以上哮喘患者的附加维持治疗，这些患者患有嗜酸性粒细胞性哮喘，这是一种与2型炎症相关的形式，其症状无法通过中高剂量的皮质类固醇加上另一种哮喘药物来控制。。

Simultaneously, the three regulators are also reviewing a second potential indication for

同时，这三个监管机构也在审查第二个潜在的指示

depemokimab

depemokimab 的

as an add-on therapy for chronic rhinosinusitis with nasal polyps (CRSwNP).

作为慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）的附加疗法。

GSK has said depemokimab is one of the top prospects in its pipeline, with peak sales potential of £3 billion ($3.7 billion) if approved across all its proposed indications.

葛兰素史克表示，depemokimab是其管道中最具前景的公司之一，如果在所有拟议适应症中获得批准，其最高销售潜力将达到30亿英镑（37亿美元）。

'Simultaneous regulatory submissions for two indications highlight our confidence in depemokimab to help reduce the burden of both asthma and CRSwNP for patients and health systems,' said Kaivan Khavandi, the group's global head of respiratory and immunology R&D.

该集团呼吸和免疫学研发全球负责人凯万·卡万迪（KaivanKhavandi）说，同时提交的两个适应症的监管文件突显了我们对depmokimab的信心，它有助于减轻患者和卫生系统哮喘和CRSwNP的负担。

Depemokimab is a follow-up to GSK's

Depemokimab是GSK的后续产品

Nucala

努卡拉

(mepolizumab), a once-monthly IL-5 inhibitor approved for severe asthma, CRSwNP, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES) that made sales of £1.3 billion in the first nine months of 2024 and is one of the company's top products.

（mepolizumab）是一种每月一次的IL-5抑制剂，被批准用于严重哮喘，CRSwNP，嗜酸性肉芽肿伴多血管炎（EGPA）和嗜酸性粒细胞增多综合征（HES），在2024年的前9个月销售额为13亿英镑，是该公司的顶级产品之一。

It is one of five key product launches that GSK is hoping to make this year along with Nucala for chronic obstructive pulmonary disorder (COPD), novel antibiotic gepotidacin, new MenABCWY meningitis vaccine, and the relaunch of cancer drug Blenrep (belantamab mafodotin).

这是葛兰素史克（GSK）今年希望推出的五个关键产品之一，包括治疗慢性阻塞性肺疾病（COPD）的Nucala、新型抗生素gepotidacin、新型MenABCWY脑膜炎疫苗以及抗癌药物Blenrep（belantamab mafodotin）的重新推出。

In the

在

SWIFT-1 and SWIFT-2

SWIFT-1和SWIFT-2

trials, depemokimab achieved a 72% reduction in clinically significant exacerbations that required hospitalisation or a visit to an emergency room, although, the drug missed the mark on some other endpoints, including lung function, asthma symptoms, and quality-of-life scores at 52 weeks.

试验中，depemokimab使需要住院或急诊室就诊的临床显着恶化减少了72%，尽管该药物在52周时错过了其他一些终点，包括肺功能，哮喘症状和生活质量评分。

Meanwhile, the

与此同时

ANCHOR-1 and ANCHOR-2

锚-1和锚-2

trials in CRSwNP showed that the drug was able to nasal polyp size as well as nasal obstruction compared to placebo over a year.

CRSwNP的试验表明，与安慰剂相比，该药物能够在一年内消除鼻息肉的大小以及鼻塞。

GSK is also running trials of the long-acting antibody in EGPA (OCEAN) and HES (DESTINY), and has suggested it may also run trials in COPD, depending on the outcome of its Nucala filing in that indication, which is based on the

GSK还在EGPA（OCEAN）和HES（DESTINY）中进行长效抗体的试验，并建议它也可能在COPD中进行试验，这取决于其在该适应症中提交Nucala文件的结果，该结果基于

MATINEE

日场

trial data. In that study, Nucala was shown to reduce exacerbations across the full spectrum of COPD patients.

试验数据。在那项研究中，Nucala被证明可以减少COPD患者全谱的恶化。

Image by

图像作者

Hopestar21

希望21

from

从

Pixabay

Pixabay 的