FDA要求阿斯利康(AstraZeneca)提供更多关于的Fasenra治疗慢性鼻窦炎伴鼻息肉的数据

2022-03-14 Allan MedSci原创

总体而言,与安慰剂相比,Benralizumab 合并标准治疗可减少鼻塞并降低嗅觉困难。

慢性鼻窦炎伴鼻息肉(CRSwNP)是常见的鼻黏膜慢性炎性疾病,其发病机制复杂,鼻塞、嗅觉减退和流涕等临床症状可严重影响患者生活质量,对人类健康的影响不亚于慢性阻塞性肺病、充血性心力衰竭和晚期肾病等。CRSwNP患者通常具有2型免疫特征,通常患有严重且反复发作的疾病。

阿斯利康(AstraZeneca)近日表示,FDA 就一项申请批准 Fasenra (benralizumab)用于治疗慢性鼻窦炎伴鼻息肉(CRSwNP)患者的申请发出了完整的回复信。该公司表示,FDA 要求提供 Fasenra (benralizumab)治疗CRSwNP的进一步临床数据,但未提供更多细节。

来自 III 期 OSTRO 试验的数据满足了两个共同主要终点,而第二个针对 CRSwNP 患者的晚期研究(被称为 ORCHID 研究)也正在进行中。Fasenra (benralizumab)目前在包括美国、欧盟和日本在内的许多国家被批准作为严重嗜酸性粒细胞哮喘的附加维持疗法。

III 期 OSTRO 研究纳入了严重 CRSwNP 患者,这些患者尽管接受了鼻内皮质类固醇治疗,但仍有症状,并且有全身性皮质类固醇 (SCS) 使用史和/或鼻息肉 (NP) 手术史。主要终点是 NP 评分 (NPS) 从基线到第 40 周的变化,以及每 2 周报告一次的患者报告的平均鼻塞评分。

III 期 OSTRO 试验的研究人群包括 413 名患者(benralizumab组 207 名,安慰剂组 206 名)。与安慰剂相比,Benralizumab 在第 40 周时显著改善了 NPS 和鼻塞评分(P ≤ 0.005)。在第 40 周,嗅觉评分的改善也有显著性 (P = 0.003)。且 Benralizumab 安全且耐受性良好。总体而言,与安慰剂相比,Benralizumab 合并标准治疗可减少鼻塞并降低嗅觉困难。

 

原始出处:

https://firstwordpharma.com/story/5524833

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    2022-07-31 bsmagic9140
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    2023-02-15 gracezdd
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