Scholar Rock 因FDA质控警告,将诺和诺德工厂从药物申请中剔除

投资观察
Aug 08

Scholar Rock Holding 正从其用于治疗脊髓性肌萎缩症的 apitegromab 生物制剂许可申请中,移除一座由诺和诺德拥有的灌装-封装设施。此举背景是,该设施因可能面临美国食品药品监督管理局的执法行动而被标记。

这家生物制药公司表示,申请将转而依托另一座灌装-封装设施继续进行——该设施位于美国,且与FDA和欧洲监管机构均保持良好记录。按计划,该申请有望在9月30日前获得FDA的批准。

Scholar Rock 透露,公司于周五收到客户通知,称FDA已将首个灌装-封装设施——即诺和诺德旗下的Catalent Indiana——在4月的一次现场检查后,归类为“官方行动指示”。据FDA解释,这一分类意味着监管和/或行政措施已被建议采取。

“Scholar Rock 将继续与FDA密切合作,并遵循其指导,将Catalent Indiana从apitegromab的BLA中移除,”公司表示。“FDA对apitegromab BLA的审查将仅依托第二座灌装-封装设施推进。”

该公司补充道,其正与欧洲药品管理局就后续步骤持续沟通,力求将第二座设施纳入其在欧洲提交的apitegromab上市许可申请中。

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