安进(AMGN.US)&阿斯利康(AZN.US)“First-in-class”疗法获FDA突破性疗法认定治疗COPD

智通财经08-12

智通财经APP获悉，日前，安进(Amgen/AMGN.US)公司在2024年第二季度财报中表示，该公司与阿斯利康(AstraZeneca/AZN.US)合作开发的“first-in-class”单抗Tezspire(tezepelumab)获得FDA授予的突破性疗法认定，作为附加维持疗法，治疗中度至极重度慢性阻塞性肺病(COPD)患者，这些患者具有嗜酸性粒细胞表型。两家公司正在计划在COPD患者中启动3期临床试验。

Tezepelumab是一款“first-in-class”人源性、靶向抗胸腺基质淋巴细胞生成素(TSLP)的单克隆抗体。TSLP是位于许多炎症级联反应顶端的上皮细胞因子，能引发对过敏性、嗜酸性和其他类型气道炎症的过度免疫反应。该疗法在2021年12月获美国FDA批准作为附加维持疗法，治疗12岁以上儿童和成人严重哮喘患者。除了重度哮喘，tezepelumab还正被开发用以治疗其他潜在适应症，包括慢性阻塞性肺病、伴有鼻息肉的慢性鼻窦炎、慢性自发性荨麻疹和嗜酸性食管炎。

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