Saphnelo皮下剂型申请遭FDA驳回，阿斯利康：承诺与FDA密切合作以尽快推进申请

格隆汇02-03

阿斯利康2月3日公告称，美国食品药品监督管理局（FDA）就Saphnelo（阿伏利尤单抗）用于成人系统性红斑狼疮患者皮下给药的生物制品许可申请发出完整答复函（CRL）。阿斯利康随后提供了CRL中要求的补充信息，并承诺与FDA密切合作以尽快推进该申请。FDA预计将于2026年上半年对更新后的Saphnelo申请作出决定。静脉注射制剂Saphnelo仍可正常上市销售。当天，FDA驳回了阿斯利康狼疮治疗...

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