IL-5拮抗剂Nucala治疗慢性鼻-鼻窦炎的临床试验:取得阳性结果

2020-04-04 Allan MedSci原创

慢性鼻-鼻窦炎(chronic rhinosinusitis, CRS)是指鼻旁窦和鼻道内衬黏膜的复杂炎性疾病且尽管尝试内科治疗、但仍持续12周或以上。

慢性鼻-鼻窦炎(chronic rhinosinusitis, CRS)是指鼻旁窦和鼻道内衬黏膜的复杂炎性疾病且尽管尝试内科治疗、但仍持续12周或以上。葛兰素史克公司(GlaxoSmithKline)近日公布的数据显示,在治疗鼻息肉患者的慢性鼻-鼻窦炎(CRSwNP)的过程中,Nucala(美泊利珠单抗)达到了关键III期SYNAPSE试验的两个主要终点。该公司指出,这标志着抗IL-5生物制剂Nucala首次在CRSwNP中报告了积极结果,葛兰素史克公司计划在2020年对该药物进行监管提交。

葛兰素史克公司首席科学官Hal Barron说:“这些结果表明Nucala可以减轻鼻息肉患者的症状”。SYNAPSE研究招募了400多名患有严重双侧鼻息肉复发的成年患者,入组患者还必须在过去10年中至少有过一次鼻息肉手术史,尽管经过了标准治疗仍具有复发性鼻息肉,并且目前需要鼻息肉手术。患者随机接受Nucala或安慰剂,均与标准护理相结合。

 

原始出处:

https://www.firstwordpharma.com/node/1713000

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    2020-04-06 tastas

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FDA:GSK的Nucala(美泊利单抗)获批用于治疗慢性鼻窦炎鼻息肉

慢性鼻窦炎是指持续时间超过 12 周的副鼻窦炎症。症状包括面部闷胀、流涕、鼻后滴流、鼻塞和全身不适。根据伴和不伴鼻息肉,慢性鼻窦炎分为两大类。

FDA批准Nucala在美国治疗高嗜酸性粒细胞综合征(HES)

FDA已批准Nucala(mepolizumab)治疗12岁及以上患有高嗜酸性粒细胞综合征(HES)的成年和儿科患者的申请。

Nucala(mepolizumab)是能显著减少高嗜酸性粒细胞综合症患者耀斑的疗法

GSK近日宣布,Nucala(mepolizumab)的一项关键研究在治疗嗜酸性粒细胞增多症(HES)患者中取得了积极成果,这使其成为第一种被证明能够减少HES耀斑的方法。

FDA批准GSK的哮喘药物Nucala新的给药方式,患者只需每四周服用一次

葛兰素史克的白细胞介素-5(IL-5)单抗Nucala(mepolizumab)已获得美国食品和药物管理局(FDA)批准使用自动注射器和预填充安全注射器,用于患者每四周服用一次。

美国FDA正式拒绝葛兰素史克的Nucala治疗COPD的申请

葛兰素史克公司2018年9月7日宣布,FDA已发布一份关于Nucala(mepolizumab)的完整回复函,否定了Nucala作为吸入皮质类固醇维持治疗的附加药物的申请,Nucala预计能够减少慢性阻塞性肺病(COPD)患者的急性嗜酸性粒细胞计数增多症。

CHMP推荐Nucala(mepolizumab)用于治疗重症嗜酸性粒细胞性哮喘的欧洲患儿

葛兰素史克近日宣布,欧洲药品管理局(EMA)的人用药品委员会(CHMP)发布了一项积极意见,建议将Nucala(mepolizumab)作为严重难治性嗜酸性粒细胞性哮喘的治疗药物,用以治疗6岁至17岁的儿科患者。