GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

葛兰素史克公司 (LSE/NYSE: GSK) 今天宣布，欧洲药品管理局 (EMA) 已接受其扩大使用Nucala (mepolizumab) 的申请，Nucala 是一种针对白细胞介素 5 (IL-5) 的单克隆抗体，可作为嗜酸性表型慢性阻塞性肺病 (COPD) 患者的辅助维持治疗。

The application is supported by results from the positive phase III MATINEE trial, which showed a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations with mepolizumab compared to placebo.1 The trial recruited patients across a wide spectrum of COPD phenotypes and clinical presentations. These data indicate that mepolizumab, in addition to inhaled maintenance therapy, offers a clinically meaningful benefit to a patient population in need of treatments to reduce their risk of exacerbations. Results of MATINEE will be presented at a future scientific congress.

该申请得到了积极的 III 期 MATINEE 试验结果的支持，该试验表明，与安慰剂相比，美泊利单抗可显著降低中度/重度急性加重的年化率，且具有临床意义。1该试验招募了各种 COPD 表型和临床表现的患者。这些数据表明，除了吸入式维持治疗外，美泊利单抗还为需要治疗以降低急性加重风险的患者群体提供了具有临床意义的益处。MATINEE 的结果将在未来的科学大会上公布。

IL-5 is a key cytokine (protein) in type 2 inflammation which is an underlying driver in many diseases.2,3,4 This type of inflammation is detected in up to 40% of patients with COPD and is a major cause of symptoms and exacerbations that can lead to hospitalisation and/or emergency room visits.

IL-5 是 2 型炎症中的关键细胞因子（蛋白质），是许多疾病的潜在驱动因素。2,3,4多达40 % 的 COPD 患者会出现这种类型的炎症，并且是导致住院和/或急诊室就诊的症状和恶化的主要原因。

COPD affects more than 390 million people globally5 and over 40 million people in Europe6. It is one of the leading causes of hospitalisation in many countries7. In 2021 alone, COPD had a societal cost of approximately 164 billion euros and resulted in more than 330,000 deaths in Europe.6 Recurrent exacerbations accelerate disease progression and further increase the risk of hospitalisation, adding to pressures on healthcare systems through emergency department visits and inpatient care.

全球有超过 3.9 亿人患有 COPD 5，欧洲有超过 4000 万人患有COPD 6。它是许多国家住院的主要原因之一7。仅在 2021 年，COPD 就给欧洲带来了约 1640 亿欧元的社会成本，导致超过 33 万人死亡。6反复发作会加速病情进展，进一步增加住院风险，并通过急诊就诊和住院护理增加医疗系统的压力。

If approved, mepolizumab could be the first biologic with monthly dosing for patients with COPD.

如果获得批准，美泊利单抗可能成为首个针对 COPD 患者每月给药的生物制剂。

Mepolizumab is currently approved for use in Europe across four IL-5 mediated conditions. These include two respiratory indications as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older and as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. Indications also include the use of mepolizumab as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA) and as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

目前，美泊利单抗已获准在欧洲用于治疗四种 IL-5 介导的疾病。其中包括两种呼吸系统适应症，作为成人、青少年和 6 岁及以上儿童严重难治性嗜酸性哮喘的辅助治疗，以及作为鼻内皮质类固醇的辅助治疗，用于治疗患有严重慢性鼻窦炎和鼻息肉的成人患者，这些患者的全身皮质类固醇治疗和/或手术无法充分控制疾病。适应症还包括将美泊利单抗作为 6 岁及以上复发缓解或难治性嗜酸性肉芽肿性多血管炎 (EGPA) 患者的辅助治疗，以及作为控制不佳的嗜酸性粒细胞增多综合征成人患者的辅助治疗，且无可识别的非血液系统继发性病因。

Mepolizumab is currently not approved for use in COPD in any country.

目前，美泊利单抗尚未在任何国家获准用于治疗 COPD。