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和黄医药:索凡替尼获美国FDA授予快速通道资格
阿思达克 04-21 12:35
和黄医药宣布,美国食品药品监督管理局(FDA)已授予索凡替尼两项快速通道资格,用於治疗不适合手术的晚期和进展性胰腺和非胰腺神经内分泌瘤(NET)。

美国FDA快速通道资格旨在加速针对严重疾病的药物开发和审批,以解决未获满足的医疗需求。获得快速通道资格的新药可能是针对特定严重疾病的首个疗法,或与现有疗法相比在临床上具有显着优势。除此之外,这类新药有可能拥有独特的作用机制,或者可令对现有疗法效果不佳或不耐受的患者获益,从而解决未满足的医疗需求。获得快速通道资格的项目可以在药物开发计划上与美国FDA进行更频繁的互动,并获取加速审批、优先审评和滚动审评资格。

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