EMA顾问小组拒绝萨诺菲的雷祖罗克(Rezurock)有罕见的免疫紊乱症, The EMA's advisory panel rejected Sanofi’s Rezurock for a rare immune disorder, despite its U.S. and other approvals.

欧洲药品署的CHMP建议不批准Sanofi的Rezurock为成人和儿童提供三线慢性移植寄主疾病治疗,尽管它在包括美国、英国和加拿大在内的20个国家已有批准。 The European Medicines Agency’s CHMP has recommended against approving Sanofi’s Rezurock for third-line treatment of chronic graft-versus-host disease in adults and children, despite its existing approvals in 20 countries including the U.S., U.K., and Canada. 该决定适用于两个年龄组,但萨诺菲对这一决定表示失望。 萨诺菲计划要求重新检查并继续支助使用该药物的患者。 The decision, which applies to both age groups, was met with disappointment by Sanofi, which plans to request a re-examination and continues to support patients with the drug. 该公司引用了有关Rezurock效能和安全的强有力的临床和真实世界数据。 The company cites strong clinical and real-world data on Rezurock’s efficacy and safety. 一个单独的EMA委员会对Sanofi的药物Wayrilz 用于免疫性血栓细胞障碍症给予了积极的意见。 A separate EMA committee gave a positive opinion on Sanofi’s drug Wayrilz for immune thrombocytopenia.