智通财经APP获悉,12月30日,CDE官网显示,赛诺菲(SNY.US)BTK抑制剂Rilzabrutinib的上市申请已获受理。根据医药魔方数据库,赛诺菲在中国开展了多项Rilzabrutinib治疗自免疾病的临床试验,包括一项针对免疫性血小板减少症(ITP)的III期研究(CTR20220447),以及一项针对温抗体型自身免疫溶血性贫血的IIb期研究(CTR20212864)。
2024年4月,赛诺菲宣布Rilzabrutinib治疗持续性或慢性免疫性血小板减少症(ITP)成年患者的III期LUNA 3研究达到了主要终点。赛诺菲当时计划基于此提交Rilzabrutinib的上市申请。如果获得批准,Rilzabrutinib将是首款获批ITP适应症的BTK抑制剂。
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