FDA要求Sarepta Therapeutics停止Elevidys的运输，此前两名患者死亡与该基因疗法有关-动脉橙

FDA要求Sarepta Therapeutics停止Elevidys的运输，此前两名患者死亡与该基因疗法有关

2025-07-18 GeneOnline 等10家媒体报道 FDA动态

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美国食品药品监督管理局（FDA）因两起与Elevidys治疗相关的患者死亡事件，计划要求Sarepta Therapeutics停止所有Elevidys的运输。Elevidys是一种用于治疗杜氏肌营养不良症的基因疗法。这些死亡报告引发了安全担忧，因此FDA采取了这一行动。这款由Sarepta Therapeutics开发的产品旨在治疗一种主要影响男孩的罕见遗传疾病。尽管这些事件仍在调查中，FDA作为预防措施履行其监管职责采取了这一行动。（摘要由动脉网AI生成）

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