GSK's Nucala (Mepolizumab) Approved in Japan for Treatment of Adults With Chronic Rhinosinusitis With Nasal Polyps
GSK's Nucala (Mepolizumab) Approved in Japan for Treatment of Adults With Chronic Rhinosinusitis With Nasal Polyps
- Nucala is the first and only biologic in Japan with a four-weekly dosing schedule for this condition
- Chronic rhinosinusitis with nasal polyps (CRSwNP) exerts significant physical and emotional burden on patients with surgery often the only option
- This is the third indication for Nucala in Japan for an IL-5 mediated condition
- Nucala是日本唯一一种具有每4周一次剂量方案的生物制品,用于这种状况。
- 慢性鼻窦炎伴鼻息肉(CRSwNP)对患者造成了重大的身体和情感负担,手术常常是唯一的选择。
- 这是Nucala在日本针对IL-5介导的状况的第三个适应症。
GSK plc (LSE/NYSE: GSK) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients, limited to those who are inadequately controlled with standard treatment.
GSk公司(LSE/NYSE:GSK)今天宣布,日本卫生劳动省批准了Nucala(美泊珠单抗),一种靶向白细胞介素-5(IL-5)的单克隆抗体,用于治疗成人患者的慢性鼻窦炎伴鼻息肉(CRSwNP),仅限于那些对标准治疗控制不佳的患者。
Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, at GSK said: "The chronic and debilitating impact that chronic rhinosinusitis with nasal polyps can have on those affected is often underestimated. This additional indication for Nucala in Japan could provide patients with an alternative treatment option to surgery or systemic steroids."
GSk的全球呼吸/免疫学研发副总裁Kaivan Khavandi表示:"长期慢性鼻窦炎伴鼻息肉对患者的持续和严重影响往往被低估。 Nucala在日本的这个额外适应症可能为患者提供一种手术或全身性类固醇的替代治疗选项。"
CRSwNP is a chronic condition that affects 1% to 4% of the general population, of whom 40% have uncontrolled disease.1,2 People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pressure, sleep disturbance and nasal discharge, which can significantly affect their emotional and physical well-being.3 In Japan, an estimated 2 million people suffer from chronic rhinosinusitis, of which about 200,000 are subject to surgery due to nasal polyps.4
CRSwNP是一种慢性病状,影响1%至4%的普通人群,其中40%的人病情无法控制。 1,2患有CRSwNP的人会出现鼻阻塞,嗅觉丧失,面部压力,睡眠障碍和鼻涕流出等症状,这些症状会严重影响他们的情感和身体健康。3在日本,估计有200万人患有慢性鼻窦炎,其中约有200,000人因鼻息肉而接受手术。 4
CRSwNP is caused by chronic inflammation of the nasal lining that can cause soft tissue growth, known as nasal polyps, that develop in the sinuses and nasal cavity.3 Over 80% of patients with CRSwNP have type 2 inflammation, which is associated with more severe disease and nasal polyp recurrence.5-8 IL-5 is a key cytokine driving this type 2 inflammation and is present at high levels in nasal polyp tissue.3,5-8 Although surgery can be effective at removing polyps, the underlying type 2 inflammation means they have a tendency to regrow.7,8
CRSwNP是慢性鼻腔粘膜炎症引起的疾病,会导致软组织生长,即鼻息肉,在鼻窦和鼻腔中发展。3超过80%的CRSwNP患者患有第二型炎症,与严重疾病和鼻息肉复发有关。5-8白细胞介素-5(IL-5)是推动这种第二型炎症的关键细胞因子,在鼻息肉组织中存在较高水平。3,5-8尽管手术可以有效清除鼻息肉,但潜在的第二型炎症意味着它们有复发的倾向。7,8
The approval is based on results of the phase III MERIT trial, which studied the efficacy and safety of mepolizumab over a 52-week period in a population of Japanese, Chinese and Russian patients with inadequately controlled CRSwNP, supported by data from the global phase III SYNAPSE study, which explored the effect of mepolizumab vs. placebo in more than 400 patients with CRSwNP.3,9
此批准是基于III期MERIt试验的结果,该试验研究了长达52周的mepolizumab在日本、中国和俄罗斯患者中的疗效和安全性,并根据全球III期SYNAPSE研究的数据提供支持,该研究探讨了mepolizumab与安慰剂在超过400名CRSwNP患者中的效果。
Mepolizumab is approved in Japan as a treatment for bronchial asthma in children aged 6 years or older and in adults with refractory asthma whose symptoms are inadequately controlled with standard treatment, and also for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) inadequately responding to the standard treatment.
Mepolizumab已在日本获批用于治疗6岁及以上儿童和成年人的支气管哮喘,并且对于症状无法得到充分控制的复发性哮喘患者,以及对标准治疗反应不足的嗜酸性肉芽肿性多发性血管炎(EGPA)的成年患者。
About the MERIT trial9
关于MERIt试验
The phase III MERIT trial the co-primary endpoints were change from baseline in nasal obstruction visual analogue scale (VAS) score during weeks 49 to 52 compared with placebo and change in endoscopic nasal polyp score at week 52 compared with placebo.1 Treatment with mepolizumab significantly improved nasal obstruction VAS score (mean treatment difference: -1.43 [95% CI: -2.37, -0.50]; p=0.003) and was associated with a numerical reduction in nasal polyp score at Week 52 (-0.43 [-0.89, 0.03]; p=0.067). Improvements in patient quality of life, as measured by the 22-item Sino-Nasal Outcome Test (SNOT-22) were demonstrated with mepolizumab versus placebo. Safety and tolerability data were consistent with the known profile of mepolizumab.3,5 A similar proportion of patients experienced on-treatment adverse events in the mepolizumab (68/84 [81%]) and placebo (65/85 [76%]) groups. In total, seven patients had treatment-related AEs (five in the placebo group and two in the mepolizumab group); none of these were SAEs.
III期MERIt试验的共同主要终点是与安慰剂相比,在第49周到第52周期间,基线鼻阻塞视觉模拟量表(VAS)评分的变化以及在第52周与安慰剂相比的内镜鼻息肉评分的变化。治疗mepolizumab显著改善了鼻阻塞VAS评分(平均治疗差异:-1.43 [95% CI:-2.37,-0.50];p=0.003),并在第52周与安慰剂相比,鼻息肉评分出现数值减少(-0.43 [-0.89,0.03];p=0.067)。使用mepolizumab与安慰剂相比,通过22项鼻窦结果测试(SNOt-22)显示了患者生活质量的改善。安全性和耐受性数据与mepolizumab的已知概况一致。在mepolizumab组(68/84 [81%])和安慰剂组(65/85 [76%])中,有相似比例的患者经历了既往治疗期间的不良事件。总共有7名患者出现与治疗相关的不良事件(安慰剂组5例,mepolizumab组2例);其中没有发生严重不良事件。
About Nucala (mepolizumab)
关于Nucala(mepolizumab)
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.10,11 IL-5 is central to the development, maturation and activation of eosinophils, a type of white blood cell implicated in the pathogenesis of asthma and CRSwNP.3 Evidence indicates that IL-5 has an impact on other cell types beyond eosinophils that contribute to inflammation in airways disease.12-16 Mepolizumab binds directly to and inhibits IL-5 molecules.10,11 Mepolizumab has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation.10,11
mepolizumab于2015年获得美国批准用于治疗具有嗜酸性表型的严重哮喘,它是一种单克隆抗体,能靶向和结合白细胞介素-5(IL-5),这是2型炎症中的关键信使蛋白(细胞因子)。IL-5对于嗜酸性粒细胞的发育、成熟和激活至关重要,这是一种与哮喘和CRSwNP发病机制相关的白细胞类型。证据表明,IL-5对除了嗜酸性粒细胞之外的其他细胞类型也有影响,这些细胞类型也参与气道疾病中的炎症。mepolizumab直接结合和抑制IL-5分子。mepolizumab已被开发用于治疗多种与2型炎症相关的IL-5介导的疾病。
GSK in respiratory
GSk在呼吸道方面的控件
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. GSK is harnessing the latest science and technology with the aim to modify underlying disease dysfunction and prevent disease progression.
GSk继续建立几十年来的开拓性工作,为数以亿计的呼吸道疾病患者提供更有雄心的治疗目标,开发下一代的标准医疗护理,并重新定义呼吸道医学的未来。凭借行业领先的呼吸道产品组合和疫苗、靶向生物制品和吸入药物的产品线,我们致力于改善哮喘和COPD等所有类型的气喘和慢阻肺患者的预后和生活,以及较少被理解的难治性慢性咳嗽或罕见疾病,如系统性硬化合并间质性肺病。GSk正在利用最新的科学和技术,旨在修复潜在疾病功能障碍并防止疾病进展。
About GSK
关于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.
GSK是一家全球生物医药公司,其目的是通过联合科学、技术和才华于疾病之前获得优势。详情请访问gsk.com。
Cautionary statement regarding forward-looking statements
关于前瞻性声明的警告声明
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2023, and GSK's Q2 Results for 2024.
GSk 提示投资者,GSk 在本公告中发表的任何前瞻性声明或预测都存在风险和不确定性,可能导致实际结果与预期结果有所不同。 这些因素包括但不限于 GSK 的 2023 年年度报告表格 20-F 的第 3.D 条“风险因素”和 2024 年第二季度业绩。