GSK的Nucala获FDA批准作为辅助治疗以减少COPD急性加重相关帖子：-动脉网

GSK Scores FDA Approval for Nucala as Add-On Treatment to Reduce COPD Exacerbations Related posts:

GeneOnline 等信源发布 2025-05-23 17:01

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by Denisse Sandoval

由丹妮丝·桑多瓦尔

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he FDA

美国食品药品监督管理局

has approved

已批准

GlaxoSmithKline’s (GSK) mepolizumab (Nucala) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. The approval is supported by results from the phase 3 MATINEE (

葛兰素史克（GSK）的美泊利单抗（Nucala）作为附加维持治疗，用于控制不佳的慢性阻塞性肺疾病（COPD）且具有嗜酸性粒细胞表型的成人患者。该批准得到了3期MATINEE试验结果的支持。

NCT04133909

) and METREX (

）和METREX（

NCT02105948

) trials, which demonstrated a reduction in the annualized rates of moderate or severe exacerbations associated with mepolizumab treatment. Following an unexpected delay earlier this month, the company has now received FDA authorization to advance its strategy.

）试验，证明了与美泊利单抗治疗相关的中度或重度恶化的年化率有所降低。在本月初出现意外延迟后，该公司现已获得FDA授权以推进其策略。

Results support mepolizumab as the only approved biologic for COPD patients with blood eosinophil counts starting at 150 cells/μL

结果支持将美泊利单抗作为唯一获批的生物制剂，用于治疗血液嗜酸性粒细胞计数从150个/μL起的COPD患者。

The approval was based on positive results from the phase 3 MATINEE and METREX trials. These studies showed that mepolizumab significantly reduced the annualized rate of moderate to severe exacerbations compared to placebo in a broad patient population. Preventing exacerbations is a critical aspect of COPD management, as these events can lead to irreversible lung damage, worsening symptoms, and increased mortality.

该批准基于三期MATINEE和METREX试验的积极结果。这些研究表明，与安慰剂相比，美泊利单抗显著降低了中度至重度急性加重的年发生率，在广泛的患者群体中表现出色。预防急性加重是慢性阻塞性肺疾病管理的关键方面，因为这些事件可能导致不可逆的肺损伤、症状恶化以及死亡率增加。

The safety profile of mepolizumab was comparable to that of placebo across the trials..

美泊利单抗的安全性在各试验中与安慰剂相当。

Currently, mepolizumab stands as the only approved biologic for COPD that researchers have evaluated in patients with a blood eosinophil count (BEC) as low as ≥150 cells/µL. Clinicians use BEC, measured through a simple blood test, as a biomarker for type 2 inflammation to assess a patient’s risk of exacerbation.

目前，美泊利单抗是唯一被批准用于COPD的生物制剂，研究人员已在血液嗜酸性粒细胞计数（BEC）低至≥150个细胞/µL的患者中对其进行了评估。临床医生通过简单的血液检测测量BEC，将其作为2型炎症的生物标志物，以评估患者急性加重的风险。

This makes BEC a valuable tool for identifying patients who may benefit from targeted biologic .

这使得BEC成为识别可能受益于靶向生物治疗的患者的宝贵工具。

therapy

治疗

, such as mepolizumab.

，例如美泊利单抗。

In the United States,

在美国，

approximately

大约

70% of COPD patients who remain inadequately controlled despite inhaled triple therapy have a BEC of 150 cells/μL or higher. This subgroup represents over one million individuals at heightened risk of exacerbations that may result in emergency department visits or hospitalizations. For these patients, .

70% 的慢性阻塞性肺疾病 (COPD) 患者尽管接受了三联吸入疗法，但仍未得到充分控制，其嗜酸性粒细胞计数 (BEC) 为 150 个细胞/μL 或更高。这一亚组代表了超过一百万的个体，他们面临加重风险，可能导致急诊就诊或住院。对于这些患者，。

adding

添加

mepolizumab to their existing treatment regimen may offer a new option to reduce exacerbation risk and improve disease control.

将美泊利单抗添加到他们现有的治疗方案中，可能会提供一种新的选择，以降低恶化风险并改善疾病控制。

“The approval of Nucala in the US provides an important option for COPD patients. Long-term follow-up studies have demonstrated that exacerbations are the single most important predictor of future risk, with particularly poor outcomes in those requiring hospital visits or admissions. Today there is hope for improved care for COPD patients with an eosinophilic phenotype, including those with a BEC threshold as low as ≥150cells/μL who need new options like Nucala to support their treatment journey,” stated Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK..

“Nucala在美国的获批为COPD患者提供了一个重要的选择。长期随访研究表明，急性加重是未来风险的最重要预测因素，尤其是那些需要就诊或住院的患者预后特别差。如今，对于具有嗜酸性粒细胞表型的COPD患者，包括嗜酸性粒细胞计数（BEC）阈值低至≥150个细胞/μL且需要像Nucala这样的新治疗选择来支持其治疗过程的患者来说，改善护理有了新的希望。” GSK全球呼吸、免疫与炎症研发负责人、高级副总裁Kaivan Khavandi表示。

COPD hospitalizations cost the U.S. healthcare system $7 billion annually

慢性阻塞性肺疾病住院治疗每年花费美国医疗系统70亿美元。

In the phase 3 clinical trials, mepolizumab significantly reduced the annualized rate of moderate or severe exacerbations in patients with an eosinophilic phenotype when added to triple inhaled therapy.

在第 3 阶段临床试验中，对于嗜酸性粒细胞表型患者，将美泊利单抗加入三联吸入疗法时，可显著降低中度或重度恶化的年化率。

In MATINEE

在午后场节目中

, the rate ratio (RR) was 0.79, and

，率比（RR）为0.79，且

in METREX

在METREX中

, the RR was 0.82. A pre-defined secondary endpoint in MATINEE also showed a reduced annualized rate of COPD exacerbations requiring emergency department visits and/or hospitalization in the mepolizumab group (RR: 0.65; 95% CI: 0.43 to 0.96), though this result was not statistically significant due to the hierarchical testing strategy. .

，RR为0.82。MATINEE研究中预先设定的次要终点也显示，美泊利单抗组中需要急诊就诊和/或住院的COPD急性加重的年化率降低（RR：0.65；95% CI：0.43至0.96），但由于分层检验策略，这一结果未达到统计学显著性。

Healthcare systems continue to shoulder a major burden from COPD hospitalizations, which experts project will become the leading cause of medical admissions. In the U.S. alone, emergency visits and inpatient care for COPD contribute to approximately $7 billion in annual direct medical costs. Currently, regulatory authorities outside the United States have not approved mepolizumab for COPD treatment.

医疗系统继续因COPD住院而承受重大负担，专家预测这将成为医疗住院的主要原因。仅在美国，COPD的急诊就诊和住院治疗每年直接医疗费用约为70亿美元。目前，美国以外的监管机构尚未批准美泊利单抗用于COPD治疗。

Regulatory submissions for approval are under review in both China and Europe..

在中国和欧洲，监管机构正在审查批准申请。

COPD

慢性阻塞性肺疾病

是

a progressive and heterogeneous inflammatory lung condition that affects over 390 million people worldwide. It includes diseases such as chronic bronchitis and emphysema and features persistent symptoms like breathlessness, chronic cough, and sputum production. These symptoms result from ongoing inflammation and progressive airflow obstruction, significantly impairing patients’ quality of life and highlighting the ongoing need for improved treatment options..

一种进展性和异质性的炎症性肺部疾病，影响全球超过3.9亿人。它包括慢性支气管炎和肺气肿等疾病，特征是持续的症状，如呼吸困难、慢性咳嗽和痰液产生。这些症状由持续的炎症和进行性的气流阻塞引起，显著降低了患者的生活质量，突显了对改进治疗方案的持续需求。

While inhaled triple therapy remains the standard of care, many patients continue to experience persistent symptoms or acute exacerbations. These exacerbations can

虽然吸入三联疗法仍然是标准治疗方法，但许多患者仍然会出现持续症状或急性加重。这些加重情况可能

lead to

导致

hospitalizations, irreversible lung damage, and increased mortality, particularly in more severe cases. As a result, there is a critical

住院治疗、不可逆的肺损伤和死亡率上升，尤其是在更严重的情况下。因此，存在一个关键问题

demand

需求

for therapies that address the underlying inflammation and reduce the risk of exacerbations in this population. Jean Wright, MD, MBA, Chief Executive Officer of the COPD Foundation said, “COPD isn’t just a disease, it’s a relentless cycle. For individuals living with COPD, managing exacerbations is an ongoing challenge, even with inhaled maintenance therapy.

针对这一人群的基础炎症治疗和降低急性加重风险的疗法。慢性阻塞性肺疾病基金会首席执行官Jean Wright医学博士、工商管理硕士表示：“慢性阻塞性肺疾病不仅仅是一种疾病，而是一个无情的循环。对于患有慢性阻塞性肺疾病的人来说，即使使用吸入性维持治疗，管理急性加重仍然是一个持续的挑战。

Biologics like mepolizumab are providing renewed optimism for those affected by COPD.”.

像美泊利单抗这样的生物制剂为受慢性阻塞性肺疾病（COPD）影响的患者带来了新的希望。

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