GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has accepted for review, data from the MATINEE study to support the regulatory review process to obtain a new indication for the use of Nucala (mepolizumab), as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

葛兰素史克股份有限公司（伦敦证交所/纽约证交所：葛兰素史克）今天宣布，美国食品和药物管理局（FDA）已接受日场研究的数据进行审查，以支持监管审查过程，以获得使用Nucala（mepolizumab）的新指征，作为嗜酸性粒细胞表型慢性阻塞性肺病（COPD）患者的附加维持治疗。

The Prescription Drug User Fee Act (PDUFA) date is 7 May 2025..

《处方药使用费法案》（PDUFA）的日期为2025年5月7日。。

The submission is based on data from the MATINEE study, which evaluated the efficacy and safety of mepolizumab in 804 patients with COPD who have evidence of type 2 inflammation characterised by blood eosinophil count.1 The trial recruited COPD patients with broad clinical presentations including hard to treat patients with emphysema-only, chronic bronchitis only, or a mix of both.

提交的资料基于日场研究的数据，该研究评估了mepolizumab对804例COPD患者的疗效和安全性，这些患者有以血液嗜酸性粒细胞计数为特征的2型炎症证据。该试验招募了具有广泛临床表现的COPD患者，包括仅难治性肺气肿患者，仅慢性支气管炎患者或两者的混合患者。

The MATINEE study met its primary endpoint with the addition of mepolizumab to inhaled maintenance therapy, achieving a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations versus placebo with patients treated for 52-104 weeks..

日场研究的主要终点是在吸入维持治疗中加入mepolizumab，与安慰剂相比，治疗52-104周的患者中/重度急性加重的年发生率有统计学意义和临床意义的降低。。

IL-5 is a key cytokine (protein) in type 2 inflammation, an inflammatory process exhibited in up to 40% of patients with COPD and the underlying pathobiology that drives symptoms and exacerbations.2-4 Type 2 inflammation is typically detected by blood eosinophil count, a biomarker, which can be measured by a simple blood test.

IL-5是2型炎症中的关键细胞因子（蛋白质），高达40%的COPD患者表现出炎症过程，并且是导致症状和恶化的潜在病理生物学。2-4 2型炎症通常通过血液嗜酸性粒细胞计数来检测，这是一种生物标志物，可以通过简单的血液测试来测量。

This test can help indicate a COPD patient’s risk of exacerbation and deterioration, their response to treatment, and inform treatment strategies in these patients.5  .

该测试可以帮助指示COPD患者恶化和恶化的风险，他们对治疗的反应，并为这些患者的治疗策略提供信息。

COPD affects more than 390 million people globally and over 14 million people in the US, exerting a significant burden on healthcare resources and the lives of patients.6-9 Recurrent exacerbations add to pressures on healthcare systems and account for a large proportion of the annual direct medical costs of COPD with emergency department visits and inpatient care costing the US healthcare system around $7 billion a year.6,8,9  .

COPD影响全球超过3.9亿人，美国超过1400万人，给医疗资源和患者的生活带来了沉重负担。6-9反复发作加重了医疗系统的压力，占COPD年度直接医疗费用的很大一部分，急诊科就诊和住院治疗每年花费美国医疗系统约70亿美元[6,8,9]。

The full results of MATINEE will be presented at a future scientific congress and form the basis of regulatory submissions around the world.

日场比赛的全部结果将在未来的科学大会上公布，并成为全球监管提交的基础。

Nucala is currently approved for use in the US across four IL-5 mediated conditions. These include two respiratory  indications as an add-on maintenance treatment for patients with severe asthma with an eosinophilic phenotype aged 6 years and older and as an add-on maintenance treatment for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and inadequate response to nasal corticosteroids.

Nucala目前被批准在美国用于四种IL-5介导的条件。这些包括两种呼吸适应症，作为6岁及以上嗜酸性粒细胞表型严重哮喘患者的附加维持治疗，以及作为慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）和对鼻皮质类固醇反应不足的成年患者的附加维持治疗。

Indications also include the use of Nucala for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) and for the treatment of patients ages 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.12 Nucala is currently not indicated for COPD anywhere in the world..

适应症还包括使用Nucala治疗成人嗜酸性肉芽肿伴多血管炎（EGPA）患者，以及治疗12岁及以上嗜酸性粒细胞增多综合征（HES）患者≥6个月，无可识别的非血液学继发原因.12 Nucala目前在世界任何地方都不适用于COPD。。

About chronic obstructive pulmonary disease (COPD) and type 2 inflammation

关于慢性阻塞性肺疾病（COPD）和2型炎症

COPD is a progressive and heterogenous inflammatory lung disease that includes chronic bronchitis and emphysema, and is the third leading cause of death resulting in more than 3 million deaths annually.5,7 Patients with COPD experience persistent respiratory symptoms such as breathlessness, cough, and sputum along with progressive airflow obstruction due to the chronic inflammation that impact daily life.5 Exacerbations are acute episodes of worsening COPD symptoms and can result in hospitalisation and irreversible lung damage that leads to progressive lung function decline.

COPD是一种进行性和异质性炎症性肺病，包括慢性支气管炎和肺气肿，是第三大死亡原因，每年导致300多万人死亡[5,7]。COPD患者出现持续的呼吸系统症状，如呼吸困难，咳嗽和痰液，以及因慢性炎症而影响日常生活的进行性气流阻塞[5]。急性加重是COPD症状恶化的急性发作，可导致住院和不可逆的肺损伤，导致进行性肺功能下降。

Exacerbations can result in a cycle of deterioration in overall physical health and increased mortality.5,12 Many patients experience persistent symptoms and exacerbations meaning there is a need for targeted therapies to address the underlying pathophysiology linked to disease progression.5,13-15.

恶化可能导致整体身体健康恶化和死亡率增加[5,12]。许多患者出现持续症状和恶化，这意味着需要有针对性的治疗来解决与疾病进展相关的潜在病理生理学[5,13-15]。

Type 2 inflammation is present in a variety of immuno-inflammatory conditions and is the underlying pathology that drives symptoms and exacerbations in up to 40% of people with COPD. 2 Blood eosinophil count is a biomarker for type 2 inflammation that can be easily measured by a simple blood test for levels of a type of white blood cell called eosinophils.

2型炎症存在于多种免疫炎症状态中，是导致高达40%的COPD患者出现症状和恶化的潜在病理。2血液嗜酸性粒细胞计数是2型炎症的生物标志物，可以通过简单的血液测试轻松测量一种称为嗜酸性粒细胞的白细胞水平。

IL-5 is a core cytokine (protein) in type 2 inflammation alongside IL-4 and IL-13.2 IL-5 is responsible for the growth, activity, and survival of eosinophils and there is now evidence to show IL-5 has broad effects on other immune and structural cell types beyond eosinophils, including those that contribute to inflammation, lung remodelling and disease progression.2,15-20 The individual role of these cell types has not been definitively established in COPD..

IL-5是2型炎症中的核心细胞因子（蛋白质），与IL-4和IL-13.2一起。IL-5负责嗜酸性粒细胞的生长，活性和存活，现在有证据表明IL-5对嗜酸性粒细胞以外的其他免疫和结构细胞类型具有广泛的影响，包括那些有助于炎症，肺重塑和疾病进展的细胞类型。2,15-20这些细胞类型的个体作用尚未在COPD中明确确定。。

About Nucala

关于Nucala

First approved in 2015 for severe asthma with an eosinophilic phenotype in the US, mepolizumab is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation. Nucala has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation. .

2015年首次在美国批准用于嗜酸性粒细胞表型的严重哮喘，mepolizumab是一种单克隆抗体，可靶向并结合白细胞介素-5（IL-5），白细胞介素-5是2型炎症中的关键信使蛋白（细胞因子）。Nucala已被开发用于治疗一系列与2型炎症相关的IL-5介导的疾病。。

About the mepolizumab development programme for COPD

关于mepolizumab COPD发展计划

The mepolizumab program in COPD is comprised of three clinical trials. The first two studies, METREX and METREO, completed in 2017. MATINEE was designed to supplement METREX and METREO, building on our learnings from these studies and IL-5 science to identify the patients who could benefit the most from Nucala and support future submissions and approvals for use in this indication.21.

COPD中的mepolizumab计划由三项临床试验组成。前两项研究METREX和METREO于2017年完成。日场旨在补充METREX和METREO，以我们从这些研究和IL-5科学中获得的知识为基础，确定哪些患者可以从Nucala中受益最大，并支持未来提交和批准用于该适应症。

About GSK in respiratory

关于呼吸系统中的GSK

GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care, and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics and inhaled medicines, we are focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease.

葛兰素史克公司继续在数十年开创性工作的基础上，为数亿呼吸系统疾病患者提供更具雄心的治疗目标，制定下一代护理标准，并重新定义呼吸医学的未来。凭借业界领先的呼吸产品组合和疫苗、靶向生物制剂和吸入药物管道，我们专注于改善患有各种类型哮喘和COPD以及不太了解的难治性慢性咳嗽或罕见疾病（如系统性硬化症伴间质性肺病）的患者的预后和生活。

GSK is harnessing the latest science and technology with the aim to modify underlying disease dysfunction and prevent disease progression. .

葛兰素史克利用最新的科学技术，旨在改变潜在的疾病功能障碍并预防疾病进展。。

About GSK

GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

葛兰素史克是一家全球性的生物制药公司，旨在联合科学、技术和人才共同战胜疾病。更多信息请访问gsk.com。