欧盟监管机构建议暂停辉瑞公司的镰状细胞病治疗药物

Reuters
26 Sep 2024

((自动化翻译由路透提供,请见免责声明 ))

路透9月26日 - 欧洲药品管理局(EMA) 周四建议暂停辉瑞公司镰状细胞病药物 Oxbryta 的上市许可。

欧洲药品管理局说,新数据引起了对Oxbryta安全性的严重担忧,并补充说,在正在进行的审查对所有可用数据进行评估之前,应暂停该药的授权、营销和供应。

本周三晚些时候,辉瑞公司表示,它将从所有获批市场上撤出 (link) Oxbryta,理由是该药存在疼痛并发症和死亡的风险。

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